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PubMed2000

The use of whole rat embryo culture as a technique for investigating potential serum toxicity in recurrent miscarriage patients.

Previously, the rat embryo model has been used as an experimental technique in investigations of the aetiology of idiopathic recurrent miscarriage. The aim of the present study was to validate it as a tool in the investigation of the aetiology of this condition. Subjects (n = 36) with a history of recurrent miscarriage were recruited from two dedicated recurrent miscarriage clinics and compared with control women with at least one previous pregnancy resulting in a live birth (n = 23). Serum from each woman was used as culture medium in the rat embryo model. Cultured embryos were scored for growth and differentiation. No statistical difference was found in any parameter between the two groups. Furthermore, patients from the recurrent miscarriage group whose serum demonstrated a trend towards lower scores, subsequently conceived and underwent uncomplicated pregnancies.

Abortion, Habitual↗
PubMed1996

[Results of long-term follow-up in treatment of endometriosis with the GnRH agonist leuprorelin acetate depot (Enantone-Gyn monthly depot)].

In a previous study 198 patients with histologically confirmed endometriosis underwent a "three-step" therapy, where surgical removal of endometriosis implants was followed by a 6 months treatment with 3.75 mg leuprorelinacetate depot as monthly subcutaneous injections and a second look laparoscopy with removal of residuals. In the following report long-term follow-up data generated in 112 of the above 198 patients on the post-treatment effect in respect to symptoms and pregnancy outcome in infertility are reported. For this purpose a special questionnaire was used. The follow-up period was up to 60 months with a median time of 33.5 months. Out of 112 patients 91 complained of infertility. 43 out of these 91 (47.3 %) became pregnant during the follow-up period, resulting in 55 pregnancies and 36 newborns. More than half of these patients conceived spontaneously, whereas in the rest stimulation programs became necessary. Recurrence of dysmenorrhoea, dyspareunia and pelvic pain was defined as recurrence of disease. During the follow-up period 70/112 (62.5 %) of the patients complained recurrence of symptoms with median first onset at 11 months. In two third symptoms were still less severe than at admission and classified as mild and moderate. The r-AFS score at first and second look laparoscopy did not differ in patients with and without recurrence of disease (p = 0.311 and 0.750). Only 28.6 % (20/70) of patients required an additional medical or surgical treatment. A subgroup of 51 patients could be evaluated in respect to quality of life and improvement of subjective conditions. Regain of quality of life and improvement of subjective conditions were reported in 54.9 % (28/51) and 52.9 % (27/51) respectively. The study results suggest that although the physiological effects of leuprorelin acetate treatment as suppression of ovarian function is rapidly reversible, the therapeutic effects linger, as evidenced by ongoing reduction of symptoms from baseline, leaving many patients asymptomatic or much improved longer than 1 year after treatment has ended. Besides long term relief and/or sustained reduction in symptom severity, the high pregnancy rate in infertility, as well as regain of quality of life and well being favour this therapeutic approach in endometriosis.

Adult↗
PubMed2000

Lifetime stressors and recurrent depression: preliminary findings of the Adult Life Phase Interview (ALPHI).

BACKGROUND: The well-established association between stress and depression is explored in a lifespan context in relation to adverse childhood experience. A new retrospective interview instrument, the Adult Life Phase Interview (ALPHI) examined the number of chronic stressors (or 'adversities') experienced over the adult life course in relation to chronic or recurrent clinical depression. The role of such lifetime adversity in mediating the relationship between childhood neglect/ abuse and adult disorder was examined. METHOD: The ALPHI uses an investigator-based, contextual approach suited to retrospective and time-linked enquiries. Reliability of the instrument was found to be satisfactory. Its association with both lifetime clinical depression and childhood neglect or abuse was examined in a community series of 198 women, consisting of 99 sister pairs, where one-half of the series was selected for having had adverse childhood experience and the other for comparison. RESULTS: Adult adversity, both at settled/fixed times and at times of major life change, was significantly higher among those with prior childhood neglect or abuse. Both a high adult adversity score and childhood neglect or abuse were related to chronic or recurrent episodes of clinical depression, with logistic regression indicating both indices contributed independently to disorder. The same results held when controls were made for sister status, given possible familial bias in experience, and for age, since women under age 25 had fewer adult phases and less adversity. CONCLUSIONS: Characteristics of adult life phases and change-points are described and the relevance of the measure for intensive survey work seeking to investigate relationships between lifespan experience and depression is discussed.

Adult↗
PubMed2003

High-concentration ethylene-vinyl alcohol copolymer and endovascular treatment of experimental aneurysms: feasibility of embolization without protection devices at the neck.

BACKGROUND AND PURPOSE: Coiling of intracranial aneurysms is both safe and effective but may be followed by recurrences. The purpose of this study was to assess the feasibility of endovascular treatment of aneurysms with high-concentration ethylene-vinyl alcohol copolymer (HCEVOH), without the use of protection devices at the neck. METHODS: Wide-necked bifurcation aneurysms with a high propensity for recurrences were constructed in 22 dogs. HCEVOH embolization was performed with a dedicated high-pressure microcatheter in 12 animals. Angiographic results at 3 and 12 weeks and pathologic results at 12 weeks were compared with those of a separate group of 10 animals treated with platinum coils. We used a qualitative scoring system to grade angiographic results, neointima formation, and recanalization at the neck. RESULTS: Intraaneurysmal HCEVOH injections could be performed without carotid emboli and without a protection device in 11 of 12 animals. Fragments detached upon traction of the microcatheters at the end of the procedure on two occasions. Immediate and late angiographic results were not significantly different between the two groups (P =.807), with a tendency for angiographic recurrences at 3 months (angiographic scores were significantly worse in both groups at 12 weeks as compared with T0 [P <.02]). A complete occlusion, including the neck, even at the cost of protrusion of material at the level of the branches, is necessary to decrease risks of recurrences. Neointima formation at the surface of the embolic agent was complete at the neck of aneurysms treated with HCEVOH. The neointimal score was significantly improved with HCEVOH as compared with coil embolization (P =.03). CONCLUSION: HCEVOH embolization of aneurysms without neck protection is feasible. It does not, however, eliminate recurrences in an experimental wide-necked aneurysm model.

Animals↗
PubMed2003

Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial.

CONTEXT: Depression and low perceived social support (LPSS) after myocardial infarction (MI) are associated with higher morbidity and mortality, but little is known about whether this excess risk can be reduced through treatment. OBJECTIVE: To determine whether mortality and recurrent infarction are reduced by treatment of depression and LPSS with cognitive behavior therapy (CBT), supplemented with a selective serotonin reuptake inhibitor (SSRI) antidepressant when indicated, in patients enrolled within 28 days after MI. DESIGN, SETTING, AND PATIENTS: Randomized clinical trial conducted from October 1996 to April 2001 in 2481 MI patients (1084 women, 1397 men) enrolled from 8 clinical centers. Major or minor depression was diagnosed by modified Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria and severity by the 17-item Hamilton Rating Scale for Depression (HRSD); LPSS was determined by the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Social Support Instrument (ESSI). Random allocation was to usual medical care or CBT-based psychosocial intervention. INTERVENTION: Cognitive behavior therapy was initiated at a median of 17 days after the index MI for a median of 11 individual sessions throughout 6 months, plus group therapy when feasible, with SSRIs for patients scoring higher than 24 on the HRSD or having a less than 50% reduction in Beck Depression Inventory scores after 5 weeks. MAIN OUTCOME MEASURES: Composite primary end point of death or recurrent MI; secondary outcomes included change in HRSD (for depression) or ESSI scores (for LPSS) at 6 months. RESULTS: Improvement in psychosocial outcomes at 6 months favored treatment: mean (SD) change in HRSD score, -10.1 (7.8) in the depression and psychosocial intervention group vs -8.4 (7.7) in the depression and usual care group (P<.001); mean (SD) change in ESSI score, 5.1 (5.9) in the LPSS and psychosocial intervention group vs 3.4 (6.0) in the LPSS and usual care group (P<.001). After an average follow-up of 29 months, there was no significant difference in event-free survival between usual care (75.9%) and psychosocial intervention (75.8%). There were also no differences in survival between the psychosocial intervention and usual care arms in any of the 3 psychosocial risk groups (depression, LPSS, and depression and LPSS patients). CONCLUSIONS: The intervention did not increase event-free survival. The intervention improved depression and social isolation, although the relative improvement in the psychosocial intervention group compared with the usual care group was less than expected due to substantial improvement in usual care patients.

Adaptation, Psychological↗
PubMed2001

Chemoprevention trials in men with prostate-specific antigen failure or at high risk for recurrence after radical prostatectomy: Application to efficacy assessment of soy protein.

This article discusses the basic elements of chemoprevention trial designs using cohorts of men following radical prostatectomy who either have prostate-specific antigen (PSA) failure indicative of recurrence or are at high risk for recurrence (positive surgical margins, extracapsular extension, seminal vesicle invasion, positive lymph nodes, Gleason score of greater than or equal to 8, preoperative serum PSA less than 20 ng/mL). Two ongoing randomized, double-blind, placebo-controlled clinical trials with soy protein as intervention in these 2 populations are described. In the trial with men at high risk for recurrence, participants started intervention within 4 months after surgery and were followed for up to 2 years; primary endpoints were PSA failure rate and time-to-PSA failure. In the trial with men with PSA failure (PSA 0.1 to 2.0 ng/mL), participants received treatment for 8 months and the primary endpoint is rise in PSA over time. The strengths and limitations of these designs are discussed and interim experience using studies with soy protein as the intervention agent are summarized.

Cohort Studies↗
PubMed1997

Role of an operative score in mitral reconstruction in dominantly stenotic lesions.

OBJECTIVE: The role of an operative score in selection and results of mitral valve reconstruction in dominantly stenotic mitral lesions was assessed. METHODS: A total of 136 patients consecutively underwent reconstruction for rheumatic mitral stenosis with or without regurgitation from December 1989 through December 1994. Mitral valve structure was scored for cuspal pliability and thickness, cuspal area loss, chordal length, papillary muscle length, annular dilatation and degree of associated regurgitation and calcification. A score of 0 indicated normal valve while a score of 24 indicated a grossly deformed valve. Age, sex, functional class, cardiac rhythm, mitral valve orifice area, left ventricular and left atrial dimensions, transmitral gradients, pulmonary artery pressures and thoroughness of repair were evaluated. RESULTS: Mitral valve architecture was disorganised moderately in 50 (37%) and severely in 69 (52%) patients. Extent of thoroughness in different operative techniques correlated with good (n = 30) or adequate (n = 60) outcome. Mean mitral valve orifice area increased from 0.77 +/- 0.2 to 2.56 +/- 0.6 cm2, peak gradient dropped from 20.3 +/- 6.2 to 8.6 +/- 3.5 torr, mean gradient from 13.5 +/- 4.9 to 4.76 +/- 2.2 torr and end-diastolic gradient from 10.1 +/- 5.0 to 3.2 +/- 1.9 torr. Lack of recognition of anatomical details and of all necessary componental measures constituted the learning curve of different operators. CONCLUSIONS: Recurrent disease, learning curve, inadequate repair and higher operative mitral valve score were the factors for poorer results in the intermediate term follow-up to 64 months. Thoroughness of repair was the most important correlate of outcome and indicative of expertise.

Adolescent↗
PubMedDate not supplied

Protein expression of Fas, Fas ligand, Bcl-2 and TGFbeta2 and correlation with survival in initial and recurrent human gliomas.

Several studies have recently demonstrated that human gliomas express Fas, Fas ligand (FasL), Bcl-2 and TGFbeta2 at some degree. These factors are considered to interact with apoptotic processes and to have immuno-reactive potential. Their role for tumor evasion from the immune surveillance is currently under examination. To date, there is only limited information about the definite expression patterns of these four factors in human gliomas, particularly in pilocytic astrocytoma (PA) and recurrent tumors. We analyzed 75 human gliomas for the immunohistochemical expression of Fas, FasL, Bcl-2, and TGFbeta2: (1) 25 PAs (WHO grade I), (2) 25 primary glioblastomas (WHO grade IV), and (3) 25 paired initial and recurrent glioblastomas (WHO grade IV), respectively. Co-expression of all four factors was present in the majority of specimens, i.e. in 72% (18/25) of PAs and 88% (47/50) of primary glioblastomas. Pilocytic astrocytomas showed significantly higher scores of TGFbeta2 expression (p < 0.05) and significantly lower Fas, Fas ligand and Bcl-2 scores (p < 0.05) than glioblastomas. There were no significant expression differences in initial versus recurrent glioblastoma specimens. Likewise, no significant correlation was observed between protein expression and clinical parameters, i.e. total survival time or progression free survival time, as documented by Kaplan-Meier method and log rank-test. In conclusion, Fas, FasL, Bcl-2 and TGFbeta2 are differently expressed in PAs versus glioblastomas. These factors, however, are not associated with patient prognosis. The broad co-expression of these factors may enable new therapeutic approaches in the future.

Adolescent↗
PubMed2004

Does tumor heterogeneity limit the use of the Weiss criteria in the evaluation of adrenocortical tumors?

Adrenal incidentalomas are detected more frequently with high-resolution imaging modalities. It is difficult to distinguish between benign and malignant lesions despite the so-called histologic Weiss criteria, imaging features, and molecular studies. We here present a 52 yr-old man who was found to have an adrenal incidentaloma during an annual check-up at his urologist. An 8 cm large adrenal lesion was detected on ultrasound, computed tomography, and magnetic resonance imaging with imaging features suggestive of malignancy. The lesion was hormonally inactive. A left-sided adrenalectomy was performed and histologic grading revealed a Weiss score of 2, suggesting a benign tumor. However, on further follow-up, the patient developed a local recurrence and pulmonary metastases diagnosed 6 yr after initial presentation. After repeat surgery in the left adrenal bed adrenocortical tumor tissue had a Weiss score of 8, clearly suggesting histologic malignancy. The patient received adjuvant mitotane therapy. Under this therapy, he developed a right-sided adrenal mass (contralateral from the primary tumor) of 2 cm size which disappeared during the following 9 months, whereas the pulmonary metastases remained unchanged, suggesting tumor clones with a variable response to treatment or spontaneous apoptosis. This case suggests that adrenal incidentalomas larger than 6 cm with imaging features such as intratumoral necrosis suggestive of malignancy, should be managed as potential cancers independent of the so-called Weiss criteria. In such patients, close follow-up examinations including high-resolution imaging (preferably 3 monthly) are needed and should be carried out by a physician familiar/specialized in endocrine oncology.

Adrenal Cortex↗
PubMed1999

Arthroscopic lavage reduced the recurrence rate following primary anterior shoulder dislocation. A randomised multicentre study with 1-year follow-up.

Young individuals have a high recurrence rate following non-operative treatment of traumatic primary anterior shoulder dislocation. The present multicentre study was undertaken to find out whether the results could be improved by using arthroscopic lavage as treatment. Sixty patients aged 16-30 years, with traumatic primary anterior shoulder dislocation were randomised into two groups. One group was treated with arthroscopic lavage within 10 days, while the other group was treated non-operatively. Rehabilitation was otherwise identical. At 1-year follow-up, 4 of 30 patients (13%) in the lavage group had had redislocation compared with 13 of 30 (43%) in the group treated non-operatively (P = 0.01). The difference in recurrence rate was more pronounced in younger patients. The functional outcome according to the Rowe shoulder score was better in the lavage group (P = 0.003), as was the anterior stability according to the apprehension test (P = 0.008). We conclude that arthroscopic lavage reduced the recurrence rate and produced a better functional outcome at 1-year follow-up than the non-operative treatment in young individuals.

Absenteeism↗
PubMed2003

Mitomycin-C in the postsurgical ear canal.

OBJECTIVE: Our goal was to evaluate the use of topical mitomycin-C (MMC) in the prevention of scar tissue formation in the postsurgical external auditory canal (EAC). Study design and setting We conducted a prospective pilot study at a tertiary care institution. METHODS: Six patients with recurrent postoperative granulation tissue after canaloplasty, tympanomastoidectomy, or lateral temporal bone resection were included. MMC (0.5 mg/mL) was applied topically for 5 minutes to the EAC/mastoid cavity. RESULTS: Outcomes were measured at initial MMC application and 1 and 3 months thereafter using a visual analog scale score based on the degree of EAC occlusion by granulation tissue. Need for debridement of recurrent granulation tissue on follow-up was noted. Three (50%) patients had improved VAS 1 month after treatment. Two (33%) had improved visual analog scale score at 3 months. Five (83%) required at least one debridement procedure. Repeat MMC application was performed in 2 patients. CONCLUSION: Topical MMC was ineffective in preventing scar formation in the postsurgical EAC.

Adult↗
PubMed1988

Local recurrence in papillary thyroid carcinoma: is extent of surgical resection important?

From a multivariate analysis of more than 20,600 patient-years' experience with papillary thyroid carcinoma (PTC), we devised a prognostic scoring system based on patient age, tumor grade, extent, and size (AGES). This scoring system was used as an adjustment variable for analyzing the role of different types of surgical treatment in the development of local recurrence (LR) in 963 PTC patients who underwent unilateral (15%), bilateral subtotal/near-total (69%), or total thyroidectomies (16%) from 1946 through 1975 at the Mayo Clinic. In 866 patients with AGES scores of 3.99 or less, the risk of LR developing at 10, 20, and 30 years was 7%, 14%, and 14% after unilateral resection and 1.5%, 2%, and 4% after bilateral resection (p less than 0.001). In 97 patients with AGES scores of 4 or more, the comparable rates were 26%, 45%, and 59% after unilateral resection and 13%, 20%, and 20% after bilateral resection (p less than 0.001). In neither the low- nor the high-risk group was there a significant difference in the frequency of LR comparing total thyroidectomy with bilateral subtotal/near-total thyroidectomy. At 30 years after diagnosis of LR, mortality from PTC was 48%; the risk of cancer death with an LR located outside the thyroid remnant was much greater than with a remnant recurrence alone. In this series of 52 patients, followed up for as many as 41 years, no patient with tumor recurrence limited to the thyroid remnant died of thyroid cancer.

Adolescent↗
PubMed1996

Suppression of experimental arthritis by gene transfer of interleukin 1 receptor antagonist cDNA.

Restoration of the impaired balance between pro- and antiinflammatory cytokines should provide effective treatment of rheumatoid arthritis. Gene therapy has been proposed as an approach for delivery of therapeutic proteins to arthritic joints. Here, we examined the efficacy of antiinflammatory gene therapy in bacterial cell wall-induced arthritis in rats. Human secreted interleukin 1 receptor antagonist (sIL-1ra) was expressed in joints of rats with recurrent bacterial cell wall-induced arthritis by using ex vivo gene transfer. To achieve this, primary synoviocytes were transduced in culture with a retroviral vector carrying the sIL-1ra cDNA. Transduced cells were engrafted in ankle joints of animals prior to reactivation of arthritis. Animals in control groups were engrafted with synoviocytes transduced with lacZ and neo marker genes. Cells continued to express transferred genes for at least 9 days after engraftment. We found that gene transfer of sIL-1ra significantly suppressed the severity of recurrence of arthritis, as assessed by measuring joint swelling and by the gross-observation score, and attenuated but did not abolish erosion of cartilage and bone. The effect of intraarticularly expressed sIL-1ra was essentially local, as there was no significant difference in severity of recurrence between unengrafted contralateral joints in control and experimental groups. We estimate that locally expressed sIL-1ra was about four orders of magnitude more therapeutically efficient than systemically administered recombinant sIL-1ra protein. These findings provide experimental evidence for the feasibility of antiinflammatory gene therapy for arthritis.

Animals↗
PubMed1997

Disease classification and transmission effects on linkage analyses in the NIMH1 bipolar disorder pedigrees.

In this analysis of bipolar affective disorder, 22 families from the NIMH1 data set were further grouped into three transmission patterns: male to male, male to female, and maternal. The data were analyzed under three classifications of affection status: Bipolar I (BPI) only, BPI and Bipolar II (BPII), and BPI, BPII, and recurrent unipolar. LINKAGE was run on each of the subsets, and SIBPAL was run on the full and grouped data sets. A lod score of 1.09 was found for marker D18S62 in the maternal subset, when classifying affecteds as BPI, BPII, or recurrent unipolar. Affected sib-pair analysis showed evidence for linkage with markers D18S62, D18S37, D18S53, D18S40, D18S45, and D18S56 in the male to male transmission groups and the full data set. Linkage was not consistently found in the maternal and father/daughter groups. These results indicate that subsetting by parental transmission may result in less heterogeneity and have significant effects on linkage findings. Studies using a broader definition of affection status may provide considerably more information for linkage.

Bipolar Disorder↗
PubMed2006

Quality of life in patients with various Barrett's esophagus associated health states.

BACKGROUND: The management of Barrett's esophagus (BE), particularly high grade dysplasia (HGD), is an area of much debate and controversy. Surgical esophagectomy, intensive endoscopic surveillance and mucosal ablative techniques, especially photodynamic therapy (PDT), have been proposed as possible management strategies. The purpose of this study was to determine the health related quality of life associated with Barrett's esophagus and many of the pivotal health states associated with Barrett's HGD management. METHODS: 20 patients with Barrett's esophagus were enrolled in a pilot survey study at a large urban hospital. The utility of Barrett's esophagus without dysplasia (current health state) as well as various health states associated with HGD management (hypothetical states as the subject did not have HGD) were measured using a validated health utility instrument (Paper Standard Gamble). These specific health states were chosen for the study because they are considered pivotal in Barrett's HGD decision making. Information regarding Barrett's HGD was presented to the subject in a standardized format that was designed to be easily comprehendible. RESULTS: The average utility scores (0-1 with 0 = death and 1 = perfect health) for the various Barrett's esophagus associated states were: BE without dysplasia-0.95; Post-esophagectomy for HGD with dysphagia-0.92; Post-PDT for HGD with recurrence uncertainty-0.93; Post-PDT for HGD with recurrence uncertainty and dysphagia-0.91; Intensive endoscopic surveillance for HGD-0.90. CONCLUSION: We present the scores for utilities associated with Barrett's esophagus as well as various states associated with the management of HGD. The results of our study may be useful in advising patients and providers regarding expected outcomes of the various HGD management strategies as well as providing utility scores for future cost-effectiveness analyses.

Aged↗
PubMed2004

Reoperative fundoplications are effective treatment for dysphagia and recurrent gastroesophageal reflux.

With wide application of antireflux surgery, reoperations for failed fundoplications are increasingly seen. This study was undertaken to document outcomes after reoperative fundoplications. Sixty-four patients, 26 men and 38 women, of average age 55 years+/-15.6 (SD), underwent reoperative antireflux surgery between 1992 and 2003. Fundoplication prior to reoperation had been undertaken via celiotomy in 27 and laparoscopically in 37. Both before and after reoperative antireflux surgery, patients scored their reflux and dysphagia on a Likert Scale (0 = none, 10 = continuous). Reoperation was undertaken because of dysphagia in 16 per cent, recurrent reflux in 52 per cent (median DeMeester Score 52), or both in 27 per cent. Failure leading to reoperation was due to hiatal failure in 28 per cent, wrap failure in 19 per cent, both in 33 per cent, and slipped Nissen fundoplication in 20 per cent. Laparoscopic reoperations were completed in 49 of 54 patients (91%); 15 had reoperations undertaken via celiotomy. Eighty-eight per cent of reoperations were Nissen fundoplications. With reoperation, Dysphagia Scores improved from 9.5+/-0.7 to 2.6+/-2.8, and Reflux Scores improved from 9.1+/-1.4 to 1.8+/-2.7. Seventy-nine per cent of patients with reflux prior to reoperation, 100 per cent with dysphagia, and 74 per cent with both noted excellent or good outcomes after reoperation. We conclude that failure after fundoplication occurs. Reoperations reduce the severity of dysphagia and reflux, thus salvaging excellent and good outcomes in most. Laparoscopic reoperations are generally possible. Reoperative fundoplications are effective treatment for dysphagia and recurrent gastroesophageal reflux, and their application is encouraged.

Adult↗
PubMed2001

Efficacy of tianeptine vs placebo in the long-term treatment (16.5 months) of unipolar major recurrent depression*

To compare the efficacy and acceptability of tianeptine vs placebo in the long-term treatment of unipolar major recurrent depression, 268 hospitalized and ambulatory patients meeting DSM III-R criteria for major depression with a 21-item Hamilton depression rating scale (HDRS) score >/= 17 and at least one episode in the previous 5 years received tianeptine in a 6-week multicenter open study. At D42, 185 responders (intention-to-treat population) were randomized for ethical reasons into two unbalanced groups to receive tianeptine 37.5 mg/day (n= 111) or placebo (n= 74) for 16.5 months; 173 of the 185 responders were defined as strict responders (per-protocol population) by an HDRS score which was both < 15 and at least halved vs D1, combined with clinical confirmation by the investigator. The groups were similar at baseline except in the severity of the depressive episode (greater in the tianeptine group: 33 vs 18%, p= 0.018). Relapse (before 6 months) and recurrence (after 6 months) were defined by an HDRS score >/= 15 and/or clinical global impression score >/= 4, and clinical confirmation by the investigator. Visits were at D63 and M3, M6, M9, M12, M15, and M18. Efficacy was measured by the number of relapses and recurrences and their time of onset (Kaplan-Meier survival curve analysis). Between D42 and M18 (intention-to-treat population), relapse and recurrence were less frequent on tianeptine vs placebo (16 vs 36%, p= 0.002). Comparison over time also showed a higher proportion of patients without relapse or recurrence on tianeptine (p< 0.001); the intergroup difference increased with follow-up duration. Secondary analysis of relapse in the intention-to-treat group showed a higher proportion on placebo (p= 0.002); secondary analysis of recurrence over time showed that the difference in the percentages of recurrence-free patients was nonsignificant in the intention-to-treat population (p= 0.067) but significant in the per-protocol population (p= 0.036) in favor of tianeptine. Acceptability did not differ between the groups. Treatment-induced adverse events were rare and mild in both groups. These data support the use of tianeptine in the long-term treatment of unipolar major recurrent depression. Relapse and recurrence were decreased two- to threefold on tianeptine vs placebo with no difference in acceptability between the two groups. Copyright 1997 Doin Editeurs

Journal Article↗
PubMed2006

Escitalopram maintenance treatment for prevention of recurrent depression: a randomized, placebo-controlled trial.

BACKGROUND: Major depressive disorder is a recurrent illness that often requires maintenance antidepressant treatment. Escitalopram is a selective serotonin reuptake inhibitor (SSRI) that has shown efficacy in both acute and continuation treatment of major depressive disorder. The current trial examined the efficacy of maintenance escitalopram treatment in preventing depression recurrence in patients who responded to acute SSRI therapy. METHOD: Patients with recurrent DSM-IV-defined major depressive disorder (>or= 2 previous episodes; baseline Montgomery-Asberg Depression Rating Scale [MADRS] score >or= 22) who had responded (MADRS score or= 22 or insufficient therapeutic response during the double-blind phase. The study was conducted between October 16, 2000, and February 4, 2003. RESULTS: A total of 234 patients who responded to acute open-label treatment with 1 of 4 SSRIs received at least 1 dose of open-label escitalopram continuation treatment. Of 164 patients who completed escitalopram continuation treatment, 139 were randomly assigned to double-blind maintenance treatment with escitalopram (N = 73) or placebo (N = 66). Mean baseline MADRS scores at the start of the maintenance phase were < 5 for both the placebo- and escitalopram-treatment groups. Time to recurrence was significantly longer in patients who received maintenance treatment with escitalopram compared with patients switched to placebo (hazard ratio = 0.26, 95% CI = 0.13 to 0.52, p < .001). Long-term escitalopram treatment was well tolerated. CONCLUSION: Maintenance treatment with escitalopram was well tolerated and significantly reduced the risk for recurrence of depression. Patients with few residual symptoms following continuation treatment with escitalopram experienced a high rate of depression recurrence when switched to placebo, demonstrating the need for maintenance therapy of recurrent major depressive disorder beyond 4 to 6 months of initial symptom resolution even if few residual symptoms are present.

Adult↗