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Fluoxetine and concomitant centrally acting medication use during clinical trials of depression: the absence of an effect related to agitation and suicidal behavior.
- Source :
-
Depression and anxiety [Depress Anxiety] 1997; Vol. 6 (1), pp. 31-9. - Publication Year :
- 1997
-
Abstract
- Concomitant use of psychoactive medications is a common practice in most clinical trials of antidepressant medications. However, the relative therapeutic impact of such use on trial results has not been the subject of much attention. We conducted a meta-analysis to determine whether concomitant use of psychoactive medications confounded the efficacy or safety results of a series of fluoxetine trials. Data were evaluated from 25 randomized, double-blind clinical trials comparing fluoxetine with placebo or a tricyclic antidepressant (TCA) in 4,016 patients with major depression. We compared incidence rates of concomitant use of anxiolytics, sedatives, and antipsychotics between treatments. In addition, we compared the change in total score for the 21-Item Hamilton Depression Rating Scale (HAMD21): incidence rates of any worsening, emergence, or improvement in psychomotor agitation; and incidence of suicidal acts and any worsening, emergence, or improvement in suicidal ideation between treatment groups among patients taking/not taking a sedative. Anxiolytic and antipsychotic drug use was uncommon (8.3% and 0.9% overall use, respectively) and did not substantially increase over time. Sedative drugs were used most often (29.6% overall), but only 29.8% of the fluoxetine-treated patients took one or more doses. Regarding efficacy, fluoxetine was superior to placebo in decreasing HAMD21 total scores among patients taking/not taking sedatives. Effects on safety were assessed by examining agitation and suicidal ideation. Use of sedatives did not affect the change in the HAMD agitation score; scores were similar in patients receiving fluoxetine, placebo, and TCAs. In all treatment groups, anxiolytic use tended to increase as the HAMD anxiety score increased. Fluoxetine was superior to placebo in treating suicidal ideation, and the concomitant use of sedatives did not influence this effect. Overall, concomitant use of psychotropic medications in the fluoxetine depression clinical trials was uncommon. Our meta-analysis demonstrated that the clinical efficacy and safety of fluoxetine were not confounded by the concomitant use of medications.
- Subjects :
- Adolescent
Adult
Aged
Aged, 80 and over
Anti-Anxiety Agents adverse effects
Anti-Anxiety Agents pharmacology
Anti-Anxiety Agents therapeutic use
Antidepressive Agents, Second-Generation therapeutic use
Antipsychotic Agents adverse effects
Antipsychotic Agents pharmacology
Antipsychotic Agents therapeutic use
Child
Drug Interactions
Drug Therapy, Combination
Female
Fluoxetine therapeutic use
Humans
Hypnotics and Sedatives adverse effects
Hypnotics and Sedatives pharmacology
Hypnotics and Sedatives therapeutic use
Male
Middle Aged
Psychiatric Status Rating Scales
Akathisia, Drug-Induced
Antidepressive Agents, Second-Generation adverse effects
Antidepressive Agents, Second-Generation pharmacology
Depressive Disorder drug therapy
Fluoxetine adverse effects
Fluoxetine pharmacology
Suicide, Attempted
Subjects
Details
- Language :
- English
- ISSN :
- 1091-4269
- Volume :
- 6
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Depression and anxiety
- Publication Type :
- Academic Journal
- Accession number :
- 9394873