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Fluoxetine versus trazodone: efficacy and activating-sedating effects.
C M Beasley1, B E Dornseif, J A Pultz
1Division of Clinical Neurosciences, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Ind. 46285.
The Journal of Clinical Psychiatry
|July 1, 1991
Summary
This study found fluoxetine and trazodone equally effective for major depressive episode. Fluoxetine caused more activation symptoms, while trazodone led to more sedation, with similar overall safety profiles.
Area of Science:
- Psychiatry
- Clinical Pharmacology
- Neuroscience
Background:
- Major depressive episode (MDE) is a prevalent psychiatric disorder requiring effective treatment.
- Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and serotonin antagonist and reuptake inhibitors (SARIs) like trazodone are common treatments for MDE.
- Understanding the comparative efficacy and safety profiles of these agents is crucial for clinical decision-making.
Purpose of the Study:
- To compare the efficacy and safety of fluoxetine and trazodone in outpatients with major depressive episode.
- To assess the incidence and temporal patterns of activation and sedation associated with each treatment.
Main Methods:
- A double-blind, randomized trial involving 126 outpatients meeting DSM-III criteria for nonpsychotic MDE.
- Patients received either fluoxetine (N=65) or trazodone (N=61) for up to 6 weeks after a 1-week placebo period.
- Efficacy was measured using the Hamilton Rating Scale for Depression (HAM-D21) and other scales; adverse events were evaluated weekly.
Main Results:
- Both fluoxetine and trazodone significantly improved HAM-D21 scores (p < .001) with similar endpoint improvements.
- Fluoxetine treatment was associated with higher rates of rhinitis and tremor, while trazodone led to more somnolence and dizziness.
- Activation symptoms (agitation, anxiety) were more frequent with fluoxetine (15.4%) than trazodone (3.3%), whereas sedation symptoms (somnolence, asthenia) were more common with trazodone (42.6%) than fluoxetine (21.5%).
Conclusions:
- Fluoxetine and trazodone demonstrated comparable efficacy and overall safety in treating major depressive episode.
- Distinct patterns of adverse events, specifically activation with fluoxetine and sedation with trazodone, were observed.
- The choice between fluoxetine and trazodone may depend on the patient's specific symptom profile and tolerability concerns regarding activation or sedation.