Search PubMed⌕ Search

Biomedical subjects

K Rickels

Publications and source records attributed to K Rickels.

At least 55 records · Page 3Linked to original sources
PubMed1996

Sertraline versus desipramine in the treatment of premenstrual syndrome: an open-label trial.

BACKGROUND: Antidepressant medications have appeared to be effective treatments for premenstrual syndrome (PMS) in several small trials. This open-label study examined the efficacy of and tolerance for a new serotonergic antidepressant compared with a traditional tricyclic antidepressant in PMS treatment. METHOD: For two menstrual cycles in women meeting well-defined criteria for PMS, an open-label comparison of the serotonin selective sertraline (N = 17) and the noradrenergic desipramine (N = 15) was performed. Dose was flexible, with a mean dose in the second cycle of 87 mg/day for sertraline and 110 mg/day for desipramine. Outcome measures were the premenstrual daily symptom report (DSR) scores and the Hamilton Rating Scale for Depression (HAM-D). RESULTS: Sertraline and desipramine reduced depressive symptoms as assessed by the HAM-D, both achieving similar reductions in the HAM-D scores. Reduction of total premenstrual symptoms as assessed by the DSR score was observably greater with sertraline, but the difference compared with desipramine was not statistically significant in this small sample. Subjects were more likely to perceive desipramine side effects as intolerable; 4 of the 15 desipramine-treated subjects discontinued compared with none in the sertraline group. Subjects who were previously treated in a PMS program without good therapeutic response were less likely to respond to either medication, suggesting a treatment-resistant group. CONCLUSION: Sertraline and possibly desipramine appear to be effective treatments for PMS. Sertraline was better tolerated, resulting in greater patient acceptance. A placebo-controlled trial in which subjects are randomly assigned to the medication is clearly needed to support or refute these preliminary findings.

1-Naphthylamine↗
PubMed1996

An open-label trial of nefazodone in high comorbidity panic disorder.

BACKGROUND: Nefazodone is a recently marketed compound with demonstrated efficacy in major depression. This study was undertaken to assess the efficacy and safety of nefazodone in a sample of panic disorder patients with a high degree of depressive comorbidity. METHOD: Fourteen patients were screened for entry into an open 8-week trial of nefazodone clinically titrated between 200-600 mg. Patients fulfilled DSM-III-R criteria for panic disorder and were allowed to enter with concurrent diagnoses of major depression, dysthymia, generalized anxiety disorder, and depression NOS. Primary outcome measures included panic attack frequency and severity and the Clinical Global Impression scale. RESULTS: At Week 8 of treatment, 10/14 patients (71%) were judged to be much or very much improved with study treatment. Panic attack frequency decreased from a mean of 5.4 at baseline to 2.1 at Week 8, reaching significance by Week 8 (p < .05) as did decreases in phobic anxiety. Improvement in panic attack severity, phobic avoidance, HAM-D, HAM-A, CGI-Severity, and Sheehan Disability Scale scores was significant by Week 4. Five of the 8 patients with comorbid major depression were responders, as were 3/5 patients with generalized anxiety disorder comorbidity. Five of 6 patients with pure panic or minor depressive symptoms responded to the study treatment. None of the patients withdrew because of side effects of nefazodone. CONCLUSION: This report presents preliminary evidence for the efficacy and tolerability of nefazodone in panic disorder and panic with comorbid depression or depressive symptoms.

Adult↗
PubMed1996

The long-term management of generalized anxiety disorder: issues and dilemmas.

Accumulating evidence suggests that a large proportion of patients diagnosed with generalized anxiety disorder suffer from a chronic or recurrent condition that is associated with a moderate amount of disability and impairment in quality of life. Acute drug therapy is well studied and appears to be highly effective in providing symptom relief, but relapse/recurrence is high. Little research has been reported that identifies predictors of recurrence or studies the clinical parameters of maintenance drug therapy, including benefit-risk assessments or optimal doses or durations of treatment.

Anti-Anxiety Agents↗
PubMed1996

Fluvoxamine for premenstrual dysphoric disorder: a pilot study.

BACKGROUND: Serotonergic agents appear to be effective treatments for premenstrual symptoms in a number of small trials. The purpose of this open-label treatment study was to collect pilot information on the efficacy of fluvoxamine for premenstrual dysphoric disorder (PDD). METHOD: Twelve women who sought medical treatment for premenstrual symptoms were evaluated. The main outcome measure was the premenstrual score from daily symptom reports (DSRs) maintained by the subjects. After a 2-month screening period, 10 subjects who met DSM-IV criteria for PDD were treated with fluvoxamine taken daily for two menstrual cycles. The mean dose at 4 weeks was 85 mg/day; at 8 weeks, all subjects took 100 mg/day. RESULTS: The mean premenstrual DSR scores improved at 4 weeks from the pretreatment baseline (paired t test, p < .0008) and remained improved at 8 weeks at approximately the same level (p < .003). Symptoms with the greatest improvement (p < .003, significant with the Bonferroni adjustment) were irritability, anxiety, feeling out of control, and decreased interest in usual activity. Sixty percent (6/10) of the subjects reported at least a 50% reduction in the DSR scores, a conservative clinical definition of improvement. The mean premenstrual Hamilton Rating Scale for Depression scores decreased from 19 at the pretreatment baseline to 9 at the 4-week evaluation. The main side effects were insomnia (N = 6), fatigue (N = 4), dry mouth (N = 4), and nausea (N = 3) and were generally mild and transient. CONCLUSION: These promising pilot data show the importance of a controlled trial over a longer time period to provide definitive information on the efficacy of fluvoxamine for premenstrual dysphoric disorder.

Adolescent↗
PubMed1995

A double-blind trial of oral progesterone, alprazolam, and placebo in treatment of severe premenstrual syndrome.

OBJECTIVE: To determine the effectiveness of oral micronized progesterone, alprazolam, and placebo in premenstrual syndrome (PMS) treatment and the effect of clinical contact on treatment responses. DESIGN: Randomized, double-blind, placebo-controlled 3-month parallel treatment arms with flexible dosage and with the length of clinical contact randomized within each treatment group. SETTING: University hospital PMS medical treatment outpatient program in obstetrics/gynecology department. SUBJECTS: Among volunteers for PMS treatment, 444 were evaluated and 185 meeting defined PMS criteria were randomized to treatment; treatment data are available for 170. There were no medical withdrawals for adverse events. INTERVENTION: A double-blinded protocol in which 300 mg of oral micronized progesterone, 0.25 mg of alprazolam, or placebo was administered four times a day from day 18 of the menstrual cycle through day 2 of the next cycle, including taper. The mean daily dose at the third treatment was 1760 mg of progesterone or 1.5 mg of alprazolam. Subjects were randomized to brief (< 20 minutes) or extended (50 minutes) visits. MAIN OUTCOME MEASURES: Daily symptom report (DSR) scored for total DSR symptoms, four DSR factors. RESULTS: Alprazolam was significantly better than placebo or progesterone for total premenstrual symptoms and DSR factors of mental function, pain, and mood. Thirty-seven percent of the alprazolam group experienced a 50% reduction in total DSR scores. There were no clinically significant withdrawal symptoms when alprazolam administration was restricted to the luteal phase. Oral micronized progesterone therapy was no better than placebo. Brief vs extended visits had no effect on treatment outcome. Treatment response was associated with severity of premenstrual symptoms at baseline but with no other diagnostic variables. CONCLUSIONS: Alprazolam has a role in PMS treatment and offers a therapy limited to the luteal phase. Oral micronized progesterone is ineffective for PMS.

Administration, Oral↗
PubMed1995

Progesterone co-administration in patients discontinuing long-term benzodiazepine therapy: effects on withdrawal severity and taper outcome.

Since recent research has suggested that the major metabolites of progesterone are barbiturate-like modulators of GABAergic function, we undertook a pilot study of the efficacy of micronized progesterone in attenuating withdrawal and facilitating discontinuation in benzodiazepine-dependent patients with a minimum of 1 year of continuous daily use. Forty-three patients taking a mean daily dose of 16.2 mg of diazepam (or its equivalent) were assigned, doubleblind, to treatment with either placebo (n = 13) or progesterone (n = 30). Progesterone was titrated to a mean daily dose of 1983 mg, and was co-administered for 3 weeks, after which the benzodiazepine was tapered by 25% per week. Progesterone (or placebo) was then continued for 4 weeks before being discontinued. There was no progesterone versus placebo difference in the severity of taper withdrawal. Withdrawal checklist change scores were 17.3 for progesterone and 16.5 for placebo (F 0.63; df 2.31; n.s.), and the Hamilton rating scale for anxiety change scores were 7.8 for progesterone and 6.3 for placebo (F 0.22; df 2.30; n.s.). There was no difference in ability to remain drug-free at 12 weeks post-taper, with 57% of progesterone-treated patients, and 58% of placebo-treated patients having a successful outcome.

Adult↗
PubMed1995

Relationships between age and symptom severity among women seeking medical treatment for premenstrual symptoms.

Age at the time of seeking treatment for premenstrual symptoms (PMS) was examined in a sample of 332 women who reported severe distress and met criteria for Late Luteal Phase Dysphoric Disorder (LLPDD). The mean age of the sample was 33.1 (+/- 5.3) years. Severity of symptoms decreased with age and was not associated with the duration of symptoms. Depression-related factors were associated with the severity of PMS, and together with the duration of symptoms, were the best discriminators between the younger (ages 20-35) and older (ages 36-44) women in this sample. These data suggest that the years of the late twenties through mid-thirties are the most vulnerable time for distressing PMS and fail to support the clinical premise that PMS worsens with age until menopause. Further longitudinal study should be conducted to confirm and extend these findings.

Adult↗
PubMed1995

Placebo-controlled comparison of the clinical effects of rapid discontinuation of ipsapirone and lorazepam after 8 weeks of treatment for generalized anxiety disorder.

One hundred and sixty patients (mean age 39.8 years; 67% female) diagnosed with generalized anxiety disorder (GAD) who had completed a prospective, 8 week, double-blind comparison of lorazepam (mean daily dose 4.2 mg) and ipsapirone (mean daily dose 19.5 mg) were rapidly tapered by a substitution of half-strength medication for 3 days, then substitution of matched placebo for an additional 11 days. Patients treated with ipsapirone showed no rebound anxiety on discontinuation, nor any other significant increase in withdrawal symptomatology compared to patients who had been prospectively treated with placebo. In contrast, patients treated with lorazepam showed significant emergent anxiety and/or withdrawal-related symptomatology by almost all clinical measures employed. Overall, 25% of patients treated with lorazepam showed rebound anxiety, and 40% of them utilized reserve medication because they found drug discontinuation to be intolerable. The clinical implications for discontinuation of benzodiazepines after short-term therapy are discussed.

Adult↗
PubMed1995

Nefazodone: aspects of efficacy.

BACKGROUND: Nefazodone hydrochloride, a 5-HT2 receptor antagonist and serotonin (5-HT) uptake inhibitor, was evaluated in four Phase 3 double-blind, imipramine- and placebo-controlled studies involving outpatients with major depression. METHOD: Patients who qualified for well-controlled efficacy trials in major depression were enrolled in a series of active- and placebo-controlled trials to establish the comparative efficacy of nefazodone and a standard tricyclic antidepressant drug. The primary efficacy measures employed were the 17-item Hamilton Rating Scale for Depression (HAM-D-17) and the Clinical Global Improvement (CGI) scale. Safety profiles were also compared as well as survival analyses of double-blind acute and continuation treatment of patients in efficacy trials. RESULTS: Three of four Phase 3 active- and placebo-controlled studies showed nefazodone to be an effective antidepressant drug with overall efficacy generally similar to that of imipramine. The remaining study did not differentiate either active drug from placebo controls. Superiority of nefazodone and imipramine over placebo was evidenced by greater improvement on core depression symptoms in addition to the primary outcome measures (HAM-D-17 and CGI). The incidence of side effects and premature treatment discontinuations for imipramine-treated patients was higher than for nefazodone therapy. Both drugs showed evidence of continuing efficacy during long-term treatment with significantly fewer dropouts (p < .05) than for placebo controls. CONCLUSION: Nefazodone, an antidepressant that modulates serotonin receptors and enhances serotonin-mediated neurotransmission, has been shown to be an effective and well-tolerated new antidepressant drug with greater patient acceptability and safety than imipramine.

Ambulatory Care↗
PubMed1994

Nefazodone and imipramine in major depression: a placebo-controlled trial.

Nefazodone is a phenylpiperazine antidepressant with 5-HT2 antagonism and 5-HT reuptake inhibition. Two hundred and eighty-three out-patients with a diagnosis of DSM-III-R major depression of at least one-month duration (65% ill for over 6 months), and a mean score of 24 on the 17-item Hamilton Rating Scale for Depression (HRSD), were randomised to treatment with nefazodone, imipramine, or placebo. The double-blind treatment period was 8 weeks in duration. Nefazodone's antidepressant efficacy was comparable with imipramine's, with both drug treatments significantly better than placebo in a variety of outcome measures. For example, after 8 weeks of therapy, 78% of nefazodone and 83% of imipramine but only 55% of placebo patients (P < 0.01) were globally much or very much improved. Nefazodone was better tolerated than imipramine, with fewer drop-outs and a lower incidence of side-effects during treatment.

Adult↗
PubMed1994

Nefazodone in the treatment of premenstrual syndrome: a preliminary study.

Nefazodone, a new phenylpiperazine antidepressant agent with serotonin type 2 antagonism and serotonin reuptake inhibition, was evaluated in two patient groups to determine its effectiveness in reducing the symptoms of premenstrual syndrome (PMS). The two studied groups were PMS patients with no coexisting major depression or dysthymia (N = 23) and PMS patients with current major depression or dysthymia, termed the premenstrual exacerbation group (N = 24). The two patient groups received open-label nefazodone for 8 weeks, with optional maintenance at the same dose for up to 1 year. The initial dose was 100 mg, titrated to 600 mg/day, on a twice-daily dosing schedule. Symptoms were assessed by the Hamilton Rating Scale for Depression and by Daily Symptom Ratings. Premenstrual symptoms improved significantly from pretreatment baseline values, with similar improvement for the PMS and premenstrual exacerbation groups. Significantly improvement occurred by the end of the first treated cycle (4 weeks of therapy), at an average dose of 245 (range, 100 to 400) mg, and was maintained thereafter. Nefazodone was well tolerated, side effects were often transient, and the most common were nausea and headache. Forty-seven of 54 patients completed 2 months of therapy, with a mean daily nefazodone dose of 319 mg at the 2-month point. A placebo-controlled study should be conducted to confirm and extend these promising preliminary findings.

Adolescent↗
PubMed1994

Comparison of venlafaxine and imipramine in the acute treatment of major depression in outpatients.

BACKGROUND: Venlafaxine is a new phenylethylamine antidepressant that exhibits monoamine reuptake inhibition. The current study evaluates the efficacy of venlafaxine compared to that of imipramine in outpatients suffering from major depression of moderate-to-marked severity. METHOD: We conducted a double-blind, placebo-controlled, 6-week treatment study of 224 outpatients who met DSM-III-R criteria for major depression, and who had a score of at least 20 on the 21-item Hamilton Rating Scale for Depression (HAM-D). Dosage was flexible and administered on a three-times-a-day schedule, with a mean maximum daily dose of 182 mg for venlafaxine and 176 mg for imipramine. RESULTS: For patients completing 6 weeks of treatment with venlafaxine, the HAM-D total score improved by 16.6 +/- 4.9 points. Improvement at 6 weeks was 13.6 +/- 6.3 points for patients treated with imipramine and 10.6 +/- 7.8 points for patients treated with placebo (p < .05 for active drug vs. placebo). Ninety percent of venlafaxine completers were rated as "much" or "very much" improved on the Clinical Global Impression-Improvement scale, compared to 79% treated with imipramine and 53% treated with placebo (p < .05). An endpoint analysis, where the last scores of patients who dropped out were carried forward to subsequent visits, showed significant efficacy only for venlafaxine and not imipramine, probably because of the higher attrition for the latter drug. Overall, both venlafaxine and imipramine were well-tolerated, with venlafaxine having a somewhat lower attrition rate due to adverse effects than imipramine (16% vs. 25%). CONCLUSION: These results, together with those of previously reported studies, suggest that venlafaxine has antidepressant efficacy comparable to that provided by available antidepressants.

Acute Disease↗
PubMed1994

[Osteopenia in chronic inflammatory bowel diseases. Results of a cross-sectional study using quantitative computerized tomography].

53 unselected patients with Crohn's disease (CD) (35 female, 18 men; mean age: 32.3 +/- 12.5 y.; mean duration of CD: 78.6 +/- 65.7 months) and 23 patients with ulcerative colitis (UC) (8 female, 15 men; mean age: 43.7 +/- 17.9 y.; mean duration of UC: 100.7 +/- 86.0 months) were examined by quantitative computertomography (lumbar spine 1-3). Incipient (manifest) osteopenia (OP) was defined as a reduced axial bone mineral density from -1 standard deviations (SD) to -2 (SD) (< -2SD) as compared to a control Group. Reduced bone mineral density was found in 30.2% (16/53) of patients with CD and 9% (2/23) with UC (p < 0.05). In particular 12/53 pts. (22.6%) with CD and 1/23 pts. (4.35%) with UC showed incipient OP, whereas 4/53 pts. (7.5%) with CD and 1/23 pts. (4.35%) with UC showed manifest OP. With respect to the location of CD the mean relative bone density (SD) was found to be significantly lower in patients with ileal involvement of CD (-0.88 +/- 0.8 SD; n = 39) as compared to patients with colonic involvement (-0.09 +/- 0.86 SD; n = 14) and UC (-0.09 +/- 0.55 SD; n = 23) (p < 0.05). No significant correlation to the duration of the disease was found. Previous therapy with steroids led to lower mineral bone density as compared to untreated patients. As a trend duration of steroid treatment and bone density were shown to be correlated inversely.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenal Cortex Hormones↗
PubMed1993

Maintenance drug treatment of panic disorder. I. Results of a prospective, placebo-controlled comparison of alprazolam and imipramine.

One hundred six patients diagnosed according to DSM-III as suffering from agoraphobia with panic disorder, panic disorder with limited phobic avoidance, or uncomplicated panic disorder entered an acute 8-week treatment phase. Patients who improved received an additional 6 months' maintenance treatment. Significantly more patients treated with alprazolam than with imipramine hydrochloride or placebo remained in therapy and experienced panic attack and phobia relief during the acute treatment phase. During the maintenance phase, neither tolerance nor daily dose increase was observed. All patients who completed the maintenance phase (27 in the alprazolam group, 11 in the imipramine group, and 10 in the placebo group) were panic free at the end of 8 months of study treatment. Alprazolam therapy was effective and well tolerated at a mean daily dose of 5.7 mg. Imipramine hydrochloride (175 mg/d) also produced significant panic relief but was associated with poor patient acceptance.

Adult↗
PubMed1993

Maintenance drug treatment for panic disorder. II. Short- and long-term outcome after drug taper.

Forty-eight patients with panic disorder completing 8 months of maintenance treatment with alprazolam (mean dose, 5.2 mg [n = 27]), imipramine hydrochloride (mean dose, 175 mg [n = 11]), or placebo (mean dose, 8.0 pills [n = 10]) underwent a gradual taper from medication over a 4-week period. A withdrawal syndrome was observed in almost all alprazolam-treated patients but in only a few imipramine- or placebo-treated patients. The clinical worsening of withdrawal symptoms after discontinuation tended to subside over the course of 3 medication-free weeks, but 33% of alprazolam-treated patients were unable to discontinue their medication regimen successfully. Severity of panic attacks at baseline but not daily alprazolam dose appeared as a significant independent predictor of taper difficulty. Forty-nine percent of the total study population continue to receive drug therapy: 82% alprazolam and 18% imipramine. Among patients who received alprazolam during study treatment and at follow-up, the mean daily dose was substantially reduced (6.1 vs 1.6 mg [n = 14]). At follow-up, after 1 year of naturalistic treatment for panic symptoms and combining 8-month completers and study dropouts, there were no significant differences in remission (68% to 71%) or in antipanic medication intake (39% to 56%) at follow-up for the three original treatment groups. However, 8-month study completers compared with study dropouts had a significantly higher remission rate (85% vs 55%).

Adult↗
PubMed1993

Antidepressants for the treatment of generalized anxiety disorder. A placebo-controlled comparison of imipramine, trazodone, and diazepam.

OBJECTIVE: The current study examines whether antidepressants, contrary to current thinking, are safe and effective treatments for generalized anxiety disorder (GAD) not complicated by depression or panic disorder. DESIGN: Randomized, double-blind, placebo-controlled, flexible-dose, 8-week treatment study comparing imipramine hydrochloride (mean maximum daily dose, 143 mg), trazodone hydrochloride (255 mg), and diazepam (26 mg). PATIENTS: Two hundred thirty patients with a DSM-III diagnosis of GAD in whom major depression and panic disorder has been excluded, and who had a Hamilton Anxiety Scale total score of at least 18. SETTING: Seventy-five percent of patients were treated in family practice settings in the community, with the remainder treated in psychiatric practices, either academic or private. RESULTS: Patients treated with diazepam showed the most improvement in anxiety ratings during the first 2 weeks of treatment, with somatic symptoms being most responsive. From week 3 through week 8 trazodone achieved comparable, and imipramine somewhat better, anxiolytic efficacy when compared with diazepam, with psychic symptoms of tension, apprehension, and worry being more responsive to the antidepressants. Among completers, moderate to marked improvement was reported by 73% of patients treated with imipramine, 69% of patients treated with trazodone, 66% of patients treated with diazepam, but only 47% of patients treated with placebo. Overall, patients treated with antidepressants reported a higher rate of adverse effects than diazepam-treated patients, but attention rates were the same across all treatments. CONCLUSIONS: The results of the study need replication, but suggest a potentially important role for antidepressants, particularly imipramine, in patients suffering from GAD.

Adult↗
PubMed1993

A comparison of paroxetine and placebo in depressed outpatients.

To compare the safety and efficacy of paroxetine (n = 167) and placebo (n = 169), data from 4 centres using the same protocol were pooled. A double-blind parallel group design was used, with therapy lasting 6 weeks. Significant differences between paroxetine- and placebo-treated patients were found on the major efficacy outcome variables by week 2 and on all efficacy variables by week 4 of the study. Improvement on the sleep factor of the Hamilton Rating Scale for Depression was found after 7 d. Observer and patient global efficacy ratings were in agreement by week 4. No serious adverse events occurred, and paroxetine had no clinically significant effects on vital signs or laboratory safety data. Side effects were more common on paroxetine and were similar to other serotonin reuptake inhibitors. In general, these were well tolerated and did not lead to dropout. Symptoms of increased arousal were not seen during early therapy.

Adolescent↗