Effects of reboxetine on anxiety, agitation, and insomnia: results of a pooled evaluation of randomized clinical trials.

Several recent clinical trials have established that reboxetine, a new selective norepinephrine reuptake inhibitor (selective NRI), is effective and safe for the treatment of major depression. However, the effects of reboxetine on specific symptoms of anxiety, agitation, and insomnia have not been reported. Data were obtained from nine short-term, double-blind, randomized clinical trials in patients with major depression.

Effects of reboxetine on Hamilton Depression Rating Scale factors from randomized, placebo-controlled trials in major depression.

Reboxetine is the first selective norepinephrine reuptake inhibitor (NRI) approved for the treatment of major depressive disorder (MDD). Although reboxetine has demonstrated efficacy for the treatment of depression, its effects on specific depressive symptoms have not been reported. We evaluated the effects of reboxetine on four Hamilton Depression Rating Scale (HAM-D) factors: psychomotor retardation, anxiety, cognitive disturbance and insomnia.

Double-blind comparison of citalopram and placebo in depressed outpatients with melancholia.

This multicenter study compared the efficacy and safety of citalopram and placebo in a population of moderately to severely depressed patients with melancholia. This randomized, double-blind, parallel-group study compared citalopram (flexible dose; 20-80 mg/day) with placebo in 180 psychiatric outpatients with a DSM-III diagnosis of major depression or bipolar disorder, depressed, who also met DSM-III criteria for melancholia. Following a 1-week placebo washout period, patients meeting study entry criteria were randomized to 4 weeks of double-blind treatment with either citalopram or placebo.

Sibutramine produces dose-related weight loss.

Objective: Sibutramine is a weight control drug that inhibits the reuptake of both serotonin and norepinephrine. In animals, it reduces food intake and increases thermogenesis and preliminary data in human beings showed weight loss. This paper reports a 24-week dose-ranging study to determine the effect of sibutramine on body weight of patients with obesity.

A 2-year study of sertraline in the treatment of obsessive-compulsive disorder.

The present study investigated the tolerability, safety profile, and anti-obsessional efficacy of sertraline, a selective serotonin reuptake inhibitor, during long-term treatment of patients with obsessive-compulsive disorder (OCD). Fifty-nine OCD patients who had completed a 1 year double-blind, fixed dose study comparing sertraline and placebo subsequently entered a 1-year open extension. Among the 51 patients who had been treated with sertraline during the double-blind phase, the mean total duration of sertraline treatment was 690 days.

Nefazodone in the treatment of severe, melancholic, and recurrent depression.

The development of a new antidepressant medication is usually accompanied by a concern as to whether or not the compound will be sufficiently effective in clinically important subgroups of patients (e.g., depressed patients with increased severity of symptomatology, patients with melancholic features, and patients whose illness is recurrent).

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.

Sertraline treatment for premature ejaculation.

This study was designed to examine the efficacy and safety of sertraline as a treatment for premature ejaculation. Fifty-two heterosexual male patients with self-reported premature ejaculation were randomly assigned to receive either sertraline or placebo. After a 1-week placebo washout period, the dose was titrated during treatment weeks 1 to 3 from 50 to 200 mg of sertraline per day until clinical response was optimal or dose-limiting adverse experiences emerged.

A placebo-controlled trial of L-365,260, a CCKB antagonist, in panic disorder.

The functional role of cholecystokinin in the central nervous system is unknown. The tetra peptide CCK-4 was previously observed to induce panic attacks in a majority of normal volunteers and patients with panic disorder. Furthermore, it had been demonstrated that pretreatment with 10-50 mg of L-365,260, a selective CCKB antagonist, blocked CCK-4 induced panic in patients with panic disorder.

A double-blind, placebo-controlled trial of two dose ranges of nefazodone in the treatment of depressed outpatients.

Background: Nefazodone hydrochloride, a 5-HT2 receptor antagonist that selectively inhibits serotonin reuptake, was evaluated in a double-blind, dose-finding study of novel design, involving 240 patients with major depression.

Method: Patients were randomly assigned to three treatment groups and received either placebo (2-6 capsules per day), a lower-dose range of nefazodone (50-300 mg/day), or a higher-dose range of nefazodone (100-600 mg/day) for 6 weeks.

Results: At the end of treatment, the Hamilton Rating Scale for Depression and the clinician- and patient-rated Inventory for Depressive Symptomatology scores showed significant improvement (p < or = .

Dothiepin versus doxepin in major depression: results of a multicenter, placebo-controlled trial. Prothiaden Collaborative Study Group.

Background: The tricyclic antidepressant dothiepin is well established in Europe, but clinical experience with the drug in the United States is limited.

Method: In a 10-week, multicenter, randomized, double-blind, placebo-controlled study in the United States, the efficacy and tolerability of dothiepin and doxepin (both administered as a 150-mg nightly dose) were compared in 579 outpatients with major depression.

Results: Patients in both active treatment groups showed significant improvements in depressive symptoms, associated anxiety, and sleep parameters compared with the placebo-treated group.

Evaluation of the safety and efficacy of quazepam for the treatment of insomnia in psychiatric outpatients.

Background: This study was conducted to further evaluate the safety and efficacy of the benzodiazepine hypnotic quazepam within the context of a clinical practice setting of psychiatric outpatients who had insomnia.

Method: A total of 2,813 adult, psychiatric outpatients were evaluated in an open-label study design. Each subject was instructed to take one 15-mg quazepam tablet each night at bedtime for 7 consecutive nights and was given a questionnaire to be completed at home upon arising each morning.

Expressive characteristics of anxiety in depressed men and women.

This study was aimed at identifying the expressive, movement, and social behaviors associated with anxiety in the syndrome of major depression. The sample consisted of 97 hospitalized male and female depressed patients. Expressive and social behaviors were evaluated prior to treatment in a structured videotaped interview.

A study comparing paroxetine placebo and imipramine in depressed patients.

These data provide evidence for the antidepressant efficacy of paroxetine. Paroxetine- and imipramine-treated patients were significantly different from placebo-treated patients, but little different to each other, on all depressive outcome measures. However, paroxetine appeared to have a possibly greater and earlier beneficial effect on anxiety symptoms associated with depression, when compared with imipramine.

Clinical management of the depressed geriatric patient: current therapeutic options.

Depression is probably the most common psychiatric illness affecting the elderly. Although depression in the elderly usually responds to treatment, it often goes unrecognized and, left untreated, may lead to considerable morbidity and mortality. Reversible causes of depression (e.

Efficacy and safety of b.i.d. doses of venlafaxine in a dose-response study.

In this study, 312 depressed outpatients received either placebo or one of three venlafaxine doses twice daily (b.i.d.

Milacemide: a placebo-controlled study in senile dementia of the Alzheimer type.

Objective: Milacemide, a MAO-B inhibitor that is also a prodrug for glycine, was tested as a treatment for senile dementia of the Alzheimer type (SDAT) because of its potential for enhancing cognition in animal models of impaired learning and memory.

Design: Double-blind, placebo-controlled, randomized clinical trial.

Setting: Sixteen study sites, both university-affiliated and private.

The effectiveness of labetalol compared to hydrochlorothiazide in hypertensive black patients.

Labetalol and hydrochlorothiazide (HCTZ) were compared for their efficacy in controlling hypertension of blacks in a prospective, double-blind study. Sixty-one adult patients with mild to moderate hypertension (standing diastolic blood pressure greater than or equal to 95 mm Hg and less than or equal to 114 mm Hg) were randomly selected to receive either labetalol 100 mg twice daily (n = 30) or HCTZ 25 mg twice daily (n = 31). The study was divided into two phases: a 4-week placebo run-in phase, during which all previous antihypertensive medication was discontinued, and a 12-week drug treatment phase.

A comparison of paroxetine, imipramine and placebo in depressed out-patients.

To compare the safety and antidepressant efficacy of paroxetine, imipramine, and placebo, data from six centres using the same protocol were pooled. A double-blind parallel-group design was used, with therapy lasting six weeks. From week 2 onwards, both the 240 paroxetine-treated and the 237 imipramine-treated patients were significantly different from the 240 placebo-treated patients, but no different from each other.

Criteria for selection of appropriate benzodiazepine hypnotic therapy.

The several benzodiazepine hypnotics currently marketed differ in onset and duration of action and in side effect profile. These differences are largely based on the varying pharmacodynamic properties of these agents. The selection of a drug for treating an individual patient should be based on consideration of these pharmacologic differences, as well as assessment of the sleep-wake disorder.

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 = .

Antidepressant efficacy of sertraline: a double-blind, placebo- and amitriptyline-controlled, multicenter comparison study in outpatients with major depression.

A double-blind, placebo- and amitriptyline-controlled comparison study was performed to evaluate the antidepressant efficacy of sertraline, a specific serotonin uptake inhibitor. Patients with DSM-III-defined major depression randomly received either sertraline (N = 149), amitriptyline (N = 149), or placebo (N = 150) once daily for the 8-week study period. The mean final daily medication dose for the all-patients group was 145 mg and 104 mg for the sertraline- and amitriptyline-treatment groups, respectively.

Sociodemographic and prior clinical course characteristics associated with treatment response in depressed patients.

A sociodemographic and clinical picture is presented of 82 depressed subjects who had an unequivocal response or lack of response to treatment with amitriptyline or imipramine. Patients with less severe depressive illness were found more likely to respond to treatment, while those with psychotic features were more likely to be treatment resistant. Sociodemographic and other prior and current clinical course variables were not predictive of treatment response in depressed patients.