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Pharmacopsychiatry 2003; 36(2): 61-69
DOI: 10.1055/s-2003-39043
Original Paper
© Georg Thieme Verlag Stuttgart · New York

Antipsychotic Efficacy of the Antidepressant Trimipramine: A Randomized, Double-blind Comparison with the Phenothiazine Perazine

S. Bender1 , H. M. Olbrich2 , W. Fischer3 , C. Hornstein4 , W. Schoene5 , P. Falkai6 , C. Haarmann3 , M. Berger2 , M. Gastpar1 on behalf of the Trimipramine Study Group7
  • 1University of Essen, Clinic for Psychiatry and Psychotherapy, Germany
  • 2University of Freiburg, Clinic for Psychiatry and Psychotherapy, Germany
  • 3Aventis Pharma Deutschland GmbH, Bad Soden, Germany
  • 4Psychiatric Center Nordbaden, Wiesloch, Germany
  • 5Psychiatric Hospital Radebeul, Germany
  • 6University of Bonn, Clinic for Psychiatry and Psychotherapy, Germany
  • 7The following members of the Trimipramine Study Group participated in the study: State Hospital for Psychiatry and Neurology, Arnsdorf: Dr. H. Heilemann, Dr. W. Schoene, Dr. M. Heim; University of Düsseldorf, Clinic for Psychiatry and Psychotherapy: Prof. Dr. W. Gaebel, Prof. Dr. P. Falkai, Dr. M. Eickhoff, PD Dr. A. Klimke, Prof. Dr. Dr. U. Sprick; State Hospital for Psychiatry, Emmendingen: Dr. H. Krzepinski, Dr. P. Hagen; University of Essen, Clinic for Psychiatry and Psychotherapy: Prof. Dr. M. Gastpar, Dr. S. Bender, Dr. M. Baier, K. Ortmann, M. Peveling, Dr. K. Render, M. Schieder, Dr. J. Wolstein; University of Freiburg, Clinic for Psychiatry and Psychotherapy: Prof. Dr. M. Berger, PD Dr. H.M. Olbrich, Dr. E. Dieckmann, Dr. R. Vauth; University of Halle, Clinic for Psychiatry and Psychotherapy: Prof. Dr. A. Marneros, Dr. K. Broich, Dr. B. Langer, Dr. K. Schlote; Psychiatric Hospital Ochsenzoll, Hamburg: Dr. J. Novikov, P. Emrich, Dr. J. Vogt; Psychiatric Center Nordbaden, Wiesloch: Dr. H.D. Middelhoff, Dr. C. Hornstein, Dr. H.E. Bisson, Dr. A. Bätz, J. Gephardt, R. Kösel, Dr. M. Schaupp, Dr. J. Schmidt, Dr. H. Schmitt, Dr. A. Schwarz, A. Will, Dr. B. Zimmer; University of Würzburg, Clinic for Psychiatry and Psychotherapy: Prof. Dr. H. Beckmann, PD Dr. M.H. Lanczik, Dr. F. Frieß.
Further Information

Publication History

Received: 22.5.2001 Revised: 10.5.2002

Accepted: 17.6.2002

Publication Date:
06 May 2003 (online)

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Background: The tricyclic antidepressant trimipramine exhibits several features (e. g., dopaminergic effect, molecular structure similar to a neuroleptic, receptor-binding profile similar to clozapine) that suggest its potential as an antipsychotic medication. The aim of the study was to investigate the antipsychotic potential of trimipramine in a controlled clinical trial comparing its antipsychotic efficacy with that of a neuroleptic. 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: Trimipramine failed to exhibit therapeutic equivalence to perazine in the dosages used. However, there was evidence of a substantial antipsychotic effect of trimipramine. It may be a useful medication if depressive symptoms in psychotic patients require antidepressant treatment or if other antipsychotics cannot be administered.

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Dr. Stefan Bender

University of Essen

Dept. of Psychiatry and Psychotherapy

Virchowstr. 174

45147 Essen

Germany

Fax: +49-201-7227-303

Email: stefan.bender@uni-essen.de