Abstract | BACKGROUND:
Clozapine, despite its side-effect burden, has been considered to be the drug of choice for patients with schizophrenia whose psychotic symptoms fail to respond adequately to other anti-psychotic drugs. There are conflicting data concerning the potential utility of olanzapine in treatment-resistant schizophrenia at doses beyond the 10- to 20-mg/day range that has proven to be effective for most nonrefractory patients with schizophrenia. OBJECTIVE: STUDY DESIGN/METHOD: This 6-month, randomized, double-blind, parallel-group study compared the efficacy and tolerability of olanzapine (mean dose, 34 mg/day; N = 19) or clozapine (mean dose, 564 mg/day; N = 21) in patients with treatment-resistant schizophrenia or schizoaffective disorder, diagnosed according to DSM-IV criteria. Outcome measures included psychopathology, cognitive performance (as assessed with a comprehensive neuropsychological test battery), and tolerability. The study was conducted between May 2000 and December 2003. RESULTS: Robust and significant (mostly p < .001) improvement in multiple measures of psychopathology, mainly between 6 weeks and 6 months of treatment, was found in both treatment groups, with no significant difference between the 2 treatments except for the Global Assessment of Functioning score, which favored clozapine (p = .01). Improvement in some domains of cognition was significant-and equivalent for both drugs, as well. Nonsignificantly different improvement in Verbal List Learning-Immediate Recall (p < .05), Controlled Word Association Test (p < .05), and Digit Symbol Substitution Test (p < .001) was found. There were no significant differences in extrapyramidal symptoms. Weight gain was significantly (p = .01) greater with olanzapine. CONCLUSIONS: CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00179231.
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Authors | Herbert Y Meltzer, William V Bobo, Ajanta Roy, Karu Jayathilake, Yuejin Chen, Aygun Ertugrul, A Elif Anil Yağcioğlu, Joyce G Small |
Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 69
Issue 2
Pg. 274-85
(Feb 2008)
ISSN: 1555-2101 [Electronic] United States |
PMID | 18232726
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antipsychotic Agents
- Serotonin Antagonists
- Benzodiazepines
- Clozapine
- Olanzapine
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Topics |
- Adult
- Antipsychotic Agents
(administration & dosage, adverse effects, therapeutic use)
- Benzodiazepines
(administration & dosage, adverse effects, therapeutic use)
- Clozapine
(administration & dosage, adverse effects, therapeutic use)
- Cognition
(drug effects)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Male
- Middle Aged
- Olanzapine
- Prospective Studies
- Psychiatric Status Rating Scales
- Psychotic Disorders
(drug therapy)
- Schizophrenia
(drug therapy)
- Schizophrenic Psychology
- Serotonin Antagonists
(therapeutic use)
- Time Factors
- Treatment Outcome
- Weight Gain
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