Abstract | BACKGROUND: METHOD: The study was begun in August 1999. The primary entry criterion was a history of failure to respond to a selective serotonin reuptake inhibitor (SSRI). Patients (N = 500) who subsequently failed to respond to nortriptyline during an open-label lead-in phase were randomly assigned to 1 of 4 treatment groups: olanzapine (6-12 mg/day) plus fluoxetine (25-50 mg/day) combination, olanzapine (6-12 mg/day), fluoxetine (25-50 mg/day), or nortriptyline (25-175 mg/day). The primary outcome measure was baseline-to-endpoint mean change in score on the Montgomery-Asberg Depression Rating Scale (MADRS). RESULTS: CONCLUSIONS: The olanzapine/fluoxetine combination did not differ significantly from the other therapies at endpoint, although it demonstrated a more rapid response that was sustained until the end of treatment. The results raised several methodological questions, and recommendations are made regarding the criteria for study entry and randomization.
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Authors | Richard C Shelton, Douglas J Williamson, Sara A Corya, Todd M Sanger, Luann E Van Campen, Michael Case, Susan D Briggs, Gary D Tollefson |
Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 66
Issue 10
Pg. 1289-97
(Oct 2005)
ISSN: 0160-6689 [Print] United States |
PMID | 16259543
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antipsychotic Agents
- Drug Combinations
- Placebos
- Serotonin Uptake Inhibitors
- olanzapine-fluoxetine combination
- Fluoxetine
- Benzodiazepines
- Nortriptyline
- Olanzapine
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Topics |
- Adult
- Antipsychotic Agents
(therapeutic use)
- Benzodiazepines
(therapeutic use)
- Depressive Disorder, Major
(diagnosis, drug therapy, psychology)
- Diagnostic and Statistical Manual of Mental Disorders
- Double-Blind Method
- Drug Combinations
- Drug Resistance
- Drug Therapy, Combination
- Female
- Fluoxetine
(therapeutic use)
- Humans
- Male
- Nortriptyline
(pharmacology, therapeutic use)
- Olanzapine
- Pilot Projects
- Placebos
- Psychiatric Status Rating Scales
(statistics & numerical data)
- Selective Serotonin Reuptake Inhibitors
(pharmacology, therapeutic use)
- Treatment Outcome
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