Biomedical subjects

M Gastpar

Publications and source records attributed to M Gastpar.

At least 19 recordsLinked to original sources

PubMed2006

Comparative efficacy and safety of a once-daily dosage of hypericum extract STW3-VI and citalopram in patients with moderate depression: a double-blind, randomised, multicentre, placebo-controlled study.

OBJECTIVE: The objective of this double-blind, randomised, placebo-controlled, multicentre clinical study was to demonstrate the non-inferiority and safety of the hypericum extract STW3-VI in a once-daily dosage regime in the treatment of moderate depression. During the 6-week treatment phase, the course of depression was documented by use of HAMD (items 1-17), the von Zerssen's Adjective Mood Scale (BfS) and the CGI scales. The primary objective of this 3-arm design study was to demonstrate the non-inferiority of hypericum extract STW3-VI (900 mg) to the SSRI citalopram (20 mg) and superiority of hypericum over placebo. METHODS: Outpatients (N = 388) suffering from moderate depression were enrolled. The safety and tolerability of hypericum extract in comparison to citalopram and placebo was investigated on the basis of CGI, the occurrence of adverse events and the investigation of laboratory parameters and vital signs. RESULTS: From almost identical baseline values of 21.9 +/- 1.2 points (hypericum extract), 21.8 +/- 1.2 points (citalopram) and 22.0 +/- 1.2 points (placebo), the HAMD score was reduced to 10.3 +/- 6.4 (hypericum extract), 10.3 +/- 6.4 (citalopram) and 13.0 +/- 6.9 (placebo), respectively. Based on this data, the statistical significant therapeutic equivalence of hypericum extract STW3-VI to citalopram (p < 0.0001) and the superiority of this hypericum extract over placebo (p < 0.0001) was demonstrated. At the end of treatment 54.2 % (hypericum extract), 55.9 % (citalopram) and 39.2 % (placebo) of the patients were assessed as therapy responders. The secondary efficacy parameters, change in BfS, CGI and amount of therapy responders showed that the hypericum group was not statistically different from the citalopram group, and significantly superior to the placebo group. Significantly more adverse events with "certain", "probable" or "possible" relation to study medication were documented in the citalopram group (hypericum: 17.2 %, citalopram: 53.2 %, placebo: 30 %). In most cases, the investigators assessed the tolerability of hypericum extract, citalopram and placebo as "good" or "very good". CONCLUSION: The non-inferiority of hypericum extract as compared to citalopram and the superiority of both active compounds to placebo were demonstrated, as well as a better safety and tolerability of hypericum extract in comparison to citalopram. These results revealed that hypericum extract STW3-VI is a good alternative to chemically defined antidepressants in the treatment of outpatients with moderate depression.

Adult↗

PubMed2006

Central sensitization of the trigeminal and somatic nociceptive systems in medication overuse headache mainly involves cerebral supraspinal structures.

Trigeminal and somatic nociceptive systems were studied in controls (n=15), episodic migraine (n=16), analgesics (n=14) and triptan-induced medication overuse headache (MOH) (n=15) before and after withdrawal. Patients with MOH and comorbid depressive symptoms and depression without headache were studied to investigate the influence of depression. Trigeminal nociception was studied by simultaneous registration of pain-related cortical potentials (PREP) and nociceptive blink reflex (nBR) following nociceptive-specific electrical stimulation of the forehead. Somatic nociception was evaluated using PREP of upper limbs. We found facilitation of both trigeminal and somatic PREP but not of nBR in MOH, which normalized after withdrawal. No differences were found comparing analgesics vs. triptan MOH. No differences were observed between controls and patients with episodic migraine and depression without headache. A transient facilitation was found of trigeminal and somatic nociceptive systems in MOH, which was more pronounced on a supraspinal level.

Adult↗

PubMed2005

Efficacy and tolerability of hypericum extract STW3 in long-term treatment with a once-daily dosage in comparison with sertraline.

OBJECTIVE: The objective of this double-blind, multi-center clinical study was to demonstrate the non-inferiority of hypericum extract versus sertraline in the treatment of moderate depression. METHODS: A total of 241 patients with a diagnosis of moderate depressive disorder (according to ICD-10 criteria) were randomized with either 50 mg sertraline or 612 mg hypericum extract (hypericum group n = 123; sertraline group n = 118). According to the study protocol, 200 patients were treated for at least 12 weeks ( n = 102 hypericum extract; n = 98 sertraline); 81 patients in the hypericum group and 80 in the sertraline group were treated after week 12 for an additional 12 weeks. Thus, most patients were treated for a period of 6 months. The primary efficacy variable was the 17-item HAMD total score at the end of the first 12-week double-blind treatment period. RESULTS: After the first 12-week treatment period, the HAMD score decreased from almost identical initial values (22.0 +/- 1.1 for hypericum and 22.1 +/- 1.1 points for sertraline) to 8.3 +/- 5.5 points (hypericum) and 8.1 +/- 5.6 points (sertraline) (mean +/- SD) in the patients treated per-protocol (PP) population. The statistical test for non-inferiority (boundary delta = 3) revealed that hypericum extract is not inferior to sertraline ( P < 0.0001). The mean difference between the treatments was 0.1995 points, with a corresponding one-sided 97.5 % confidence interval (-infinity, 1.3772). In patients who continued treatment in the follow-up phase, the HAMD score at the end of the study was 5.7 +/- 4.8 points (hypericum group) and 7.1 +/- 6.3 points (sertraline group). Comparable improvement was also found for the von Zerssen's Adjective Mood Scale (BfS) and CGI during the first and second 12-week treatment period in both treatment groups. With 68.6 % of patients in the hypericum group and 70.4 % in the sertraline group, the percentage of patients rated as responders did not differ significantly between treatment groups (12 weeks). The adverse events of 12 patients in the hypericum group (9.8 %) and of 16 patients in the sertraline group (13.6 %) were possibly related to study medication. No basic differences in the treatment groups were observed and no interaction with concomitant medication was documented. In most cases , the investigators assessed the tolerability of hypericum extract and sertraline as "good" or "very good." CONCLUSIONS: The results indicate that hypericum extract STW 3 is not inferior to sertraline and that it is a well-tolerated drug for the treatment of moderate depression. These favorable effects were achieved with a once-daily dose of 612 mg of hypericum extract given for up to 24 weeks.

Adolescent↗

PubMed2005

The intensity dependence of auditory evoked ERP components predicts responsiveness to reboxetine treatment in major depression.

INTRODUCTION: The intensity (loudness)-dependent amplitude change (IDAP) of auditory evoked event-related potential (ERP) components has been suggested as an indicator of central serotonergic neurotransmission. In patients with major depression, associations of high IDAP with favorable SSRI treatment outcome have been reported. This is the first study to assess the predictive value of the IDAP in SNRI treatment. METHODS: We evaluated the pre-treatment intensity-dependent change of auditory evoked P1, N1, P2, and P1/N1 and N1/P2 peak-to-peak amplitudes in 14 inpatients with major depressive episode (DSM IV) in the course of 24 days of treatment with the SNRI reboxetine (6-12 mg/d). RESULTS: Our data revealed a highly significant correlation between lower intensity-dependent N1 amplitude slopes prior to reboxetine treatment and stronger decrease of HDRS total score at Fz ( r = 0.86, P < 0.001), Fcz ( r = 0.91, P < 0.001), and Cz ( r = 0.93, P < 0.001). CONCLUSION: This result corroborates the hypothesis of the IDAP as a differential indicator of serotonergic versus noradrenergic antidepressant psychopharmacotherapy.

Acoustic Stimulation↗

PubMed2005

Group psychotherapy for opiate addicts in methadone maintenance treatment--a controlled trial.

A controlled trial was conducted evaluating cognitive-behavioural group psychotherapy as a measure to reduce concomitant drug use in methadone maintenance treatment (MMT). 73 opiate addicts were randomly assigned to local routine MMT or to routine MMT plus group psychotherapy (20 sessions over 20 weeks). Psychotherapy was delivered by therapists according to a manual. Drug use (urine screen) was compared at onset of psychotherapy, end of intervention period (6 months after study onset), and 6 months later. Data analysis was done according to intention-to-treat principles. Results indicated that patients in the psychotherapy group (n = 41) showed less drug use than control subjects (n = 32). This group difference was statistically significant at 6-month follow-up (p = 0.02). These findings underscore the usefulness of group psychotherapy in MMT. The delayed effect is comparable to other studies evaluating cognitive-behavioural psychotherapy.

Adult↗

PubMed2005

Use of illegally acquired medical opioids by opiate-dependent patients in detoxification treatment.

Take-home dosages in maintenance treatment are of great therapeutic importance, but they include the risk of the substitute being distributed illegally. We reviewed the extent of consumption of illegally acquired medical opiates by 142 opiate- or poly-addicted patients consecutively admitted to a detoxification ward. 76 (53.5%) of them admitted to taking illegally acquired medical opiates, usually methadone, at least once. The cumulative duration was 30 days (median). Motivation was usually due to difficulties in acquiring heroin, however one third reported use in an attempt at self-detoxification or as transition before entering maintenance treatment. Maintenance patients were usually the source of the opiates. The results prove the necessity of stringent conditions for take-home dosages, and illustrate deficits in the health care system.

Adult↗

PubMed2005

Sustained improvement of clinical outcome with risperidone long-acting injectable in psychotic patients previously treated with olanzapine.

The efficacy and tolerability of risperidone long-acting injectable were investigated in patients with schizophrenia or other psychotic disorders who had previously been symptomatically stable on olanzapine treatment. Patients received risperidone long-acting injectable, 25 mg, by intramuscular injection every 2 weeks; the dose could be increased to 37.5 or 50 mg if necessary. Patients were transferred directly from their previous medication to risperidone long-acting injectable without a run-in period of oral risperidone treatment. Of 192 patients recruited, 134 patients (70%) completed the study. The principal reasons for discontinuation were withdrawal of consent (8%), adverse events (6%), insufficient response (5%) and non-compliance (4%). Risperidone long-acting injectable produced a significant improvement (p = 0.0001) in Positive and Negative Syndrome Scale (PANSS) total scores, from 74.2+/-21.3 at baseline to 65.8+/-21.4 at endpoint. There were also significant reductions in PANSS subscales (positive symptoms, negative symptoms, general psycho-pharmacology) and Marder factor scores. The Clinical Global Impression increased significantly from baseline to endpoint (p = 0.0001), as reflected by the increase in the proportion of patients rated as 'not ill' or 'borderline ill' from 10% at baseline to 21% at endpoint. Risperidone long-acting injectable was also associated with significant improvements in Global Assessment of Function, patient satisfaction with treatment, and quality of life, measured on the SF-36 scale. Movement disorders, measured on the Extrapyramidal Symptom Rating Scale, were significantly reduced following the change to risperidone long-acting injectable. Treatment with risperidone long-acting injectable was well tolerated, and no significant weight gain occurred during the study. This open study suggests that risperidone long-acting injectable produces symptomatic improvement in schizophrenia patients previously considered symptomatically stable with olanzapine, along with improvement in movement disorders. The combination of improved efficacy and good tolerability may have important implications for patient adherence to therapy and subsequent long-term outcomes.

Adult↗

PubMed2004

Determination of human plasma levels of levo-alpha-acetylmethadol and its metabolites by gas chromatography-mass spectrometry.

A gas chromatography-mass spectrometry (GC-MS) method is presented which allows the simultaneous determination of the plasma concentrations of the levo-alpha-acetylmethadol (LAAM) and of its active metabolites (NorLAAM and DiNorLAAM), after derivatization with the reagent trifluoroacetic anhydride (TFAA). No interferences from endogenous compounds were observed following the extraction of plasma samples from 11 different human subjects. The standard curves were linear over a working range of 5-200ng/ml for the three compounds. Recoveries measured at three concentrations ranged from 47 to 67% for LAAM, from 50 to 69% for NorLAAM and from 28 to 50% for DiNorLAAM. Intra- and interday coefficients of variation determined at three concentrations ranged from 5 to 13% for LAAM, from 3 to 9% for NorLAAM and from 5 to 13% for DiNorLAAM. The limits of quantitation of the method were found to be 4ng/ml for the three compounds. No interference was noted from methadone. This sensitive and specific analytical method could be useful for assessing the in vivo relationship between LAAM's blood levels, clinical efficacy and/or cardiotoxicity

Analgesics, Opioid↗

PubMed2004

[Subjective experience of a computer-assisted cognitive training by patients with schizophrenia].

Cognitive training is an important aim of treatment for patients with schizophrenia. However, computer-based cognitive training is still not widely used, and there are reservations concerning the use of computers in psychiatric treatment. In a multicentre study, 64 patients with schizophrenia were investigated before and after completing a 5-week course of computer-based cognitive training using the program Cogpack. In addition to self-rating of computer anxiety (CARS) and subjective well-being (SWN), patients underwent semistructured interviews evaluating attitudes towards the training. The training was rated as highly acceptable by patients and experienced as very effective. Patients' expectations of possible training effects were largely met. The training ranked high in patients' judgement compared with other treatments received. Besides improvement in cognitive function (primary effect), patients enjoyed the training and reported increased self-esteem and progress in using computers (secondary effects). Computer anxiety scores at onset of treatment did not exceed normal values. After completion of the training, these scores were significantly reduced and subjective well-being significantly increased.

Adolescent↗

PubMed2004

[Aripiprazole: a new atypical antipsychotic drug].

Aripiprazole is an atypical antipsychotic agent with an intrinsic dopamineagonist activity of 30 %. Aripiprazole exerts additional partial agonist action on 5-HT (1A) receptors and has antagonist properties at 5-HT (2A) receptors. Controlled studies demonstrated an effectiveness in acute relapse of schizophrenic psychosis, chronical schizophrenic and schizoaffective disorders. Aripiprazole was effective in the treatment of productive psychotic and negative symptoms. Compared to other antipsychotics aripiprazole demonstrated a favourable profile of side effects: only slight changes of body weight, mild extrapyramidal symptoms, no prolactin elevation and no significant changes in QTc interval. The efficacy in the long term treatment of schizophrenia seems to be similar to other antipsychotics (e. g. olanzapine). The first evaluations of studies with patients with bipolar disorders showed a significant efficacy in the treatment of mania.

Antipsychotic Agents↗

PubMed2004

[Analysis of a special consultation for attention deficit/hyperactivity disorder in adults].

It is increasingly recognised that one-third to one-half of children diagnosed as having attention deficit/hyperactivity disorder (ADHD) continue to exhibit symptoms of the disorder into adulthood. The purpose of this study was to report on the demographic and clinical profile of 85 adults (50 men, 35 women) who presented with adult ADHD and meet DSM-IV criteria for the disorder. Patients underwent a diagnostic work-up consisting of medical, psychiatric and demographic evaluation. Deficits in educational and social competence could be demonstrated in more than one third of the patients. Male patients consulted the out-patient service on the average earlier than female patients. Only a small percentage of the population was pretreated in childhood or adolesence. Highest degrees of comorbidity were found for substance abuse and mood disorders. Anxiety disorders and personality disorders were also frequently present in ADHD patients. Patients remained predominantly in the special out-patient service, transfer to GPs was inhibited by the currently off-label use of the prescribed drugs. Guidelines need to be drawn up to establish handover from paediatric to adult ADHD care.

Adolescent↗

PubMed2004

[Atomoxetine for the treatment of attention-deficit/hyperactivity disorder].

Atomoxetine is a selective noradrenaline reuptake inhibitor that has been studied for use in the treatment of attention-deficit/hyperactivity disorder (ADHD). In vitro, ex vivo and in vivo studies have shown that atomoxetine is a highly selective antagonist of the presynaptic norepinephrine transporter with little or no affinity for other noradrenergic receptors or other neurotransmitter transporters or receptors. So far, two open-label and seven randomised, double-blind, placebo-controlled, clinical trials have been published, six in youths and three in adults. Each of these trials has shown a positive response as measured by the primary efficacy measures, the ADHD-IV Rating Scale (ADHD RS) or the Conners Adult ADHD Rating Scale (CAARS). Atomoxetine has generally been well tolerated. The most common treatment-related adverse event was decreased appetite. Atomoxetine shows no abuse potential and is not a controlled substance in the US. In November of 2002 the FDA approved atomoxetine for use in the US for the treatment of ADHD in children, adolescents and adults. Atomoxetine is the first nonstimulant approved by the FDA for the treatment of ADHD and the first medication approved for the treatment of adult ADHD.

Adolescent↗

PubMed2003

[Life events and contact behaviour in drug-related death].

The purpose of the study was to analyse influencing factors on drug-related death. Contact behaviour and life events in the forefield of drug-related death were of special interest. During a period of 5 years 189 drug-related deaths were investigated in the German town Essen (inhabitants about 600,000). 53.4 % of 189 people with drug-related death had contact to specialised institutes for drug addicts during lifetime. However, only about 15 % of this group contacted these institutes over the period of the last three months. Additionally, 26 of the 189 persons had a psychiatric comorbid diagnosis, and this subgroup also demonstrated a restricted contact behaviour. Life events during lifetime and especially during the last 3 months seemed to be of influence upon the circumstances of drug-related death. According to this study, there seems to exist a turning away from professional institutions towards the end of the drug career which makes the documentation of influencing factors on drug-related death more difficult. Turning away from the help system is not the reason for drug-related death, but an important attendant circumstance.

Comorbidity↗

PubMed2003

Treatment of anxiety, tension and restlessness states with Kava special extract WS 1490 in general practice: a randomized placebo-controlled double-blind multicenter trial.

The efficacy and tolerability of 150 mg/d Kava special extract WS 1490 were investigated in a randomized, placebo-controlled, double-blind multicenter study in patients suffering from neurotic anxiety (DSM-III-R diagnoses 300.02, 300.22, 300.23, 300.29, or 309.24). 141 adult, male and female out-patients received 3 x 1 capsule of 50 mg/d WS 1490 or placebo for four weeks, followed by two weeks of observation without study-specific treatment. During randomized treatment the total score of the Anxiety Status Inventory (ASI) observer rating scale showed more pronounced decreases in the WS 1490 group than in the placebo group. Although a treatment group comparison of the post-treatment ASI scores was not significant (p > 0.05), an exploratory analysis of variance across the differences between treatment end and baseline, with center as a second factor, showed superiority of the herbal extract over placebo (p < 0.01, two-sided). 73% of the patients treated with WS 1490 exhibited ASI score decreases > 5 points versus baseline, compared to 56% for placebo. Significant advantages for WS 1490 were also evident in a structured well-being self-rating scale (Bf-S) and the Clinical Global Impressions (CGI), while the Erlangen Anxiety, Tension and Aggression Scale (EAAS) and the Brief Test of Personality Structure (KEPS) showed only minor treatment group differences. Although the results show consistent advantages for WS 1490 over placebo in several psychiatric scales and indicate significant improvements in the patients' general well-being, the differences versus placebo were not as large as in previous trials which employed 300 mg/d of the same extract. WS 1490 was well tolerated, with no influence on liver function tests and only one trivial adverse event (tiredness) attributable to the study drug.

Administration, Oral↗

PubMed2002

[Delusional depression as differential dementia of the Alzheimer type diagnosis].

For several years, a 68-year-old patient had been treated for a dementia of Alzheimer's type and finally admitted to a closed gerontopsychiatric nursing home. According to information from his relatives, he first developed psychotic symptoms 3 years prior to admission in our psychiatric department. Several months later, he developed a lack of drive, lack of interests, and reduced emotional reaction. After a standard diagnostic work-up (psychiatric, neurological, and general medical examination, CSF examination, laboratory analyses, cranial computerized tomography), we began electroconvulsive therapy (ECT) with a working hypothesis of major depression with psychotic symptoms. The ECT was able to ameliorate rapidly the psychiatric status of the patient. After 10 weeks of inpatient treatment, he could be discharged from the hospital and was able to take up his usual professional activities on a voluntary basis. This article describes the need for an early differential diagnosis of dementias. Standardized and differential diagnoses of dementias are necessary for an antidementive therapy as well as for the detection of potentially curable diseases.

Aged↗

PubMed2002

Gender differences in depression. Epidemiological findings from the European DEPRES I and II studies.

BACKGROUND: While there is ample evidence that the prevalence rates for major depressive disorder (MDD) in the general population are higher in women than in men, there is little data on gender differences as regard to symptoms, causal attribution, help-seeking, coping, or the consequences of depression. METHOD: The large DEPRES Study dataset covering representative population samples of six European countries (wave I: 38,434 men and 40,024 women; wave II: 563 men and 1321 women treated for depression) was analyzed for gender differences. RESULTS: In wave I marked gender differences were found in the six-month prevalence rate for major depression but less so for minor depression; the gender differences for major depression persisted across all age groups. Even after stratification by clinically significant impairment and paid employment status, men reported fewer symptoms than women; as a consequence, men reached the diagnostic threshold less often. In wave II there were clear gender differences in causal attribution and in coping. Men coped by increasing their sports activity and consumption of alcohol and women through emotional release and religion. Women felt the effects of depression in their quality of sleep and general health, whereas men felt it more in their ability to work. LIMITATIONS: The second wave of the study comprises treated depressives only and may be less representative than the first wave.

Adaptation, Psychological↗

PubMed2002

[Psychopharmacotherapy of bipolar affective diseases].

The broadening of the classification systems for manic-depressive illness towards a spectrum of bipolar disorders implicates a more differentiated use of pharmacotherapies. However, many questions still remain open. This implies that all consensus guidelines and recommendations have to be considered as preliminary. On the other hand, research in the last decade has developed many new treatment alternatives, both for mood stabilizers and antidepressants as well as antipsychotics. These recommendations, which have been developed in the process of two consensus meetings, try to consider the broadening of the concept of bipolar disorder by differentiating between subgroups according to acute symptomatology and characteristics of the long-term course, e.g., rapid cycling. In particular, the emerging role and new indications of mood stabilizing antiepileptic drugs, atypical antipsychotics, and new antidepressants will be discussed.

Antidepressive Agents↗

PubMed2002

[Does maintenance treatment reduce the mortality rate of opioid addicts?].

Reduction of mortality is a basic goal of methadone maintenance treatment (MMT) for opioid addicts. During the last years, however, there have been reports about drug related deaths of MMT patients and of untreated drug addicts who had consumed illegally purchased methadone. To evaluate the supposed beneficial effect of MMT on mortality, data from a multicentre trial in the German state of North Rhine-Westphalia were analysed. 244 patients with long histories of opioid addiction and previous failures in at least two abstinence oriented treatments were observed for at least four years and up to eight years after admission to MMT. With 32 deaths out of 244 participants, the mortality rate for the whole sample was 2.5 % p.a. This rate is not remarkably different from estimations for opioid addicts in general. However, addicts in continuous maintenance treatment had a mortality rate of only 1.6 % p.a., in contrast to a rate of 8.1 % p.a. for addicts who had left treatment. These results are supported by other long-term studies with large patient samples. Therefore it is concluded that methadone maintenance treatment is a measure to reduce the mortality in opioid addicts. Attainment of this goal is threatened, however, by deviations from safety standards, especially if take-home privileges are granted too widely.

Adult↗