Abstract | BACKGROUND: METHOD: In a German multi-center, randomized, double-blind trial, the antipsychotic efficacy of trimipramine was compared with that of the phenothiazine neuroleptic perazine, using the Brief Psychiatric Rating Scale (BPRS), the Positive and Negative Syndrome Scale (PANSS), and Clinical Global Impressions (CGI). Antidepressant efficacy of both agents was measured by use of the Bech-Rafaelsen Melancholia Scale (BRMES). Ninety-five patients with acute schizophrenia (DSM-III-R) and a BPRS total score > 40 at baseline were treated with either 300-400 mg trimipramine or 450-600 mg perazine for 5 weeks. RESULTS: Therapeutic equivalence of both treatments (in the dosages used) could not be demonstrated (change in BPRS total score, per-protocol [PP] analysis, one-sided equivalence testing). However, intention-to-treat (ITT) as well as PP analysis showed a statistically significant decrease in the BPRS total scores in both treatment groups (PP: trimipramine, 56.5 +/- 9.8 to 44.1 +/- 17.9; perazine, 56.4 +/- 10.8 to 37.9 +/- 12.9). Significant decreases in all BPRS and PANSS subscores as well as CGI results and response rate support the antipsychotic efficacy of trimipramine. The BRMES total scores significantly decreased in both treatment groups without showing a significant difference between the two agents. Trimipramine was better tolerated than perazine and did not elicit extrapyramidal symptoms. CONCLUSION:
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Authors | S Bender, H M Olbrich, W Fischer, C Hornstein, W Schoene, P Falkai, C Haarmann, M Berger, M Gastpar, Trimipramine Study Group |
Journal | Pharmacopsychiatry
(Pharmacopsychiatry)
2003 Mar-Apr
Vol. 36
Issue 2
Pg. 61-9
ISSN: 0176-3679 [Print] Germany |
PMID | 12734763
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antidepressive Agents
- Antipsychotic Agents
- Trimipramine
- Perazine
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Topics |
- Antidepressive Agents
(administration & dosage, therapeutic use)
- Antipsychotic Agents
(administration & dosage, therapeutic use)
- Brief Psychiatric Rating Scale
- Double-Blind Method
- Hospitalization
- Hospitals, Psychiatric
- Humans
- Perazine
(administration & dosage, therapeutic use)
- Psychotic Disorders
(diagnosis, drug therapy, rehabilitation)
- Schizophrenia
(diagnosis, drug therapy, rehabilitation)
- Severity of Illness Index
- Trimipramine
(administration & dosage, therapeutic use)
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