Fluvoxamine for children and adolescents with obsessive-compulsive disorder: a randomized, controlled, multicenter trial.

Objective: To determine the safety and efficacy of fluvoxamine for the treatment of children and adolescents with obsessive-compulsive disorder (OCD) with a double-blind, placebo-controlled, multicenter study.

Method: Subjects, aged 8 to 17 years, meeting DSM-III-R criteria for OCD were recruited from July 1991 to August 1994. After a 7- to 14-day single-blind, placebo washout/screening period, subjects were randomly assigned to fluvoxamine 50 to 200 mg/day or placebo for 10 weeks.

Fluvoxamine maleate in the treatment of depression: a single-center, double-blind, placebo-controlled comparison with imipramine in outpatients.

The efficacy and safety of fluvoxamine maleate, a selective serotonin reuptake inhibitor, was compared with placebo and imipramine in patients with major depressive disorder. Previous literature has cited a dose range of 100 to 300 mg/day of fluvoxamine maleate for the treatment of major depression; however, this study demonstrates that a dose range of 50 to 150 mg/day is as effective as imipramine (80-240 mg/day). After a 1- to 2-week, single-blind, placebo washout phase, 150 depressed outpatients were randomized to double-blind treatment with fluvoxamine maleate (50-150 mg/day), imipramine (80-240 mg/day), or placebo for 6 weeks.

Pilot study of MK-462 in migraine.

MK-462 is a potent, selective 5HT1D receptor agonist which may be useful in treating acute migraine. We conducted a double-blind placebo-controlled inpatient study to assess the preliminary efficacy and safety of oral doses of MK-462 20 mg (n = 8) and 40 mg (n = 36) vs placebo (n = 21), administered to 65 male and post-menopausal female migraine patients aged 22-51 with moderate or severe migraine headache. Headache severity and functional disability were measured at 0.

Sertraline safety and efficacy in major depression: a double-blind fixed-dose comparison with placebo.

In a 6-week, randomized, double-blind, multicenter trial, sertraline 50 mg, 100 mg, or 200 mg, or placebo, was administered once daily to 369 patients with DSM-III-defined major depression. Efficacy variables included changes from baseline scores for total Hamilton Rating Scale for Depression (HAMD), HAMD Bech Depression Cluster, Clinical Global Impressions (CGI) Severity, CGI Improvement, and Profile of Mood States Depression/Dejection Factor. For the evaluable-patients analysis, all sertraline groups showed significantly (p < 0.

A double-blind placebo-controlled study of Org 3770 in depressed outpatients.

90 patients between 18 and 65 years, with a DSM-III diagnosis of moderate or severe major depressive episode, were randomized to 6 weeks of treatment with Org 3770 or placebo in a double-blind trial. On main efficacy parameters, the 17-item HAMD, MADRS and CGI, Org 3770 was significantly superior to placebo (P < or = 0.05) in weeks 1-4 and at endpoint and recommended as continuation treatment to significantly more patients.

A double-blind comparison of paroxetine with imipramine in the long-term treatment of depression.

The chronic and recurrent nature of major depression is well recognized, and recent data suggest that maintenance therapy with full-dose pharmacotherapy (i.e., the dose used to treat the index episode) is effective in preventing relapse and recurrence.

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.

Paroxetine versus placebo: a double-blind comparison in depressed patients.

Background: Paroxetine is a potent and selective serotonin reuptake inhibitor (SSRI). The present study assessed the efficacy and tolerability of paroxetine against placebo in depressed outpatients.

Method: A double-blind, parallel-group study was undertaken in four stand-alone centers.

A double-blind comparison of paroxetine and placebo in the treatment of depressed outpatients.

A double-blind, placebo-controlled, randomized trial was carried out to compare the efficacy and tolerability of paroxetine in outpatients with moderate to moderately severe depression without mania. Paroxetine was found to be an effective antidepressant drug when compared to placebo. For most of the measures of efficacy the benefit appeared after two weeks of therapy, but sleep was improved after one week.

The safety and efficacy of paroxetine compared with placebo in a double-blind trial of depressed outpatients.

Considerable research shows that serotonin dysfunction is implicated in major depression. Paroxetine is an investigational antidepressant that appears to act by selectively blocking neuronal serotonin uptake. Seventy-two outpatients with moderate-to-severe major depression entered this 6-week, double-blind comparison of paroxetine and placebo.

Double-blind, multicenter comparison of sertraline and amitriptyline in elderly depressed patients.

Two hundred forty-one elderly depressed patients entered the 8-week, double-blind phase of this parallel-group, multicenter study; 161 patients were randomized to receive sertraline (50-200 mg/day) and 80 were randomized to receive amitriptyline (50-150 mg/day). Among evaluable patients, there were no statistically significant differences between treatments in any of the primary efficacy variables: change in total Hamilton Rating Scale for Depression (HAM-D) score (17 items), percentage change in HAM-D score, change in HAM-D Item 1, change in Clinical Global Impressions (CGI) Severity score, change in the Depression Factor of the 56-item Hopkins Symptom Checklist, and the CGI Improvement score at the last visit. Similar results were obtained using data from all patients (intention-to-treat analysis), except that amitriptyline was superior in HAM-D Total score (p = .

The risks and benefits of clozapine versus chlorpromazine.

Clozapine is an atypical antipsychotic drug with reduced risk of unwanted neurological effects in comparison with other drugs. In this multicenter study, 151 hospitalized schizophrenic patients were randomly assigned to treatment under double-blind conditions to assess the antipsychotic efficacy and safety of clozapine versus chlorpromazine. All patients exhibited tardive dyskinesia or other extrapyramidal side effects associated with at least two prior neuroleptics.

Review of clinical and laboratory experiences with molindone hydrochloride.

The literature concerning the pharmacokinetics, pharmacodynamics, receptor physiology, and clinical use of molindone is reviewed. Unanswered questions about the drug are addressed. Although molindone is reputed to have a short half-life (1.

Comparison of the electrocardiographic effect of dothiepin and amitriptyline.

Electrocardiograms of 65 patients treated with dothiepin, a sulphur substituted tricyclic antidepressant, were compared to those of 57 patients receiving amitriptyline and 62 patients given placebo. Amitriptyline produced an average heart rate increase of 10 beats/minute as compared to 5 beats/minute for dothiepin (p less than .02).

Multicenter placebo-controlled evaluation of nomifensine treatment in depressed outpatients.

Outpatients aged 18-65 who met Feighner et al. criteria for primary affective disorder-depression and had Hamilton Depression Rating Scale (HDRS) scores greater than or equal to 20 were randomly assigned to receive nomifensine (N = 61) or placebo (N = 63) for 4 weeks. On all measures of efficacy (HDRS, Clinical Global Impressions, Hopkins Symptom Check List, Brief Psychiatric Rating Scale), patients treated with nomifensine showed significant improvement compared to placebo patients; improvement was evident after 1 week on some scales.

Kinetic evaluation of platelet monoamine oxidase following relaxation in chronic anxiety.

The effect of relaxation training, utilizing EMG biofeedback, on platelet monoamine oxidase (MAO) activity was examined in patients with a history of chronic anxiety. Anxiety scores and MAO activity were significantly lowered after 4 weeks of therapy. Kinetic studies, using phenylethylamine as substrate, indicated a significant increase of the Km constant while the Vmax showed no significant or consistent variation.

Somatic symptoms in depression and antidepressants.

Somatic side effects of antidepressant medications and of depression and anxiety were quantified in depressed patients before and after 4 weeks of treatment with amitriptyline (N = 11), or desipramine (N = 12). The entire group showed significant posttreatment decreases in depression. Side-effect symptoms were significantly reduced after treatment in the amitriptyline group; less reduction was seen in the desipramine group.

Zimeldine tolerability in comparison to amitriptyline and placebo: findings from a multicentre trial.

Zimeldine tolerability was compared to amitriptyline and placebo in a large multicentre study performed at three clinical research units in the U.S.A.

A double-blind evaluation of zimelidine in comparison to placebo and amitriptyline in patients with major depressive disorder.

This paper presents the results from a large multicenter study, performed at three clinical research units in the USA. Prior to a three to seven days of placebo washout period, patients were randomly assigned to zimelidine, a potent and selective 5-HT reuptake blocker, amitriptyline or placebo. The scheduled treatment period was four weeks.

A study of physician attitude on biofeedback.

A study of physician attitudes on biofeedback was conducted among members of the Harris County Medical Society, Harris County, Texas. The sample was drawn to match the proportionate representation in the society by speciality. Findings indicated that over 62% of the respondents had little knowledge of biofeedback, over 86% did not use biofeedback in their practice, 21.

Cholinesterase enzymes in the blood of patients with Alzheimer's disease.

Plasma pseudocholinesterase activity was about 100% higher in patients with Alzheimer's type dementia than in similar age controls. Red cell acetylcholinesterase activity tended to be lower in patients than controls. Administration of lecithin substantially increased plasma choline levels but did not alter activity of either of the cholinesterase enzymes.