Abstract | OBJECTIVE: METHOD: This 8-week, double-blind, randomized, placebo-controlled, 2-center study compared 30 mg/d of PREG (PREG-30), 200 mg/d of PREG (PREG-200), 400 mg/d of DHEA, and placebo as an adjunctive treatment of 58 chronic schizophrenia or schizoaffective disorder patients (DSM-IV). The data were collected from February 2005 until June 2007. The outcome measures were symptomatic and neurocognitive changes, functioning, and tolerability as assessed primarily by the Clinical Global Impressions-Severity of Illness scale and the Positive and Negative Syndrome Scale. Analyses are presented for 44 patients who completed 8 weeks of treatment and for 14 noncompleters. RESULTS: Compared with subjects who received placebo, those administered PREG-30 had significant reductions in positive symptom scores and extrapyramidal side effects (EPS) and improvement in attention and working memory performance, whereas subjects treated with PREG-200 did not differ on outcome variable scores for the study period. The general psychopathology severity and general functioning of patients receiving placebo and PREG-30 improved more than that of those subjects treated with DHEA, while EPS improved more in subjects treated with DHEA than in patients receiving placebo. Negative symptoms and akathisia were not significantly benefited by any treatment. The administration of PREG and DHEA was well tolerated. CONCLUSIONS: Low-dose PREG augmentation demonstrated significant amelioration of positive symptoms and EPS and improvement in attention and working memory performance of schizophrenia and schizoaffective disorder patients. Further double-blind controlled studies are needed to investigate the clinical benefit of pregnenolone augmentation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00174889.
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Authors | Michael S Ritsner, Anatoly Gibel, Tatyana Shleifer, Igor Boguslavsky, Ahmad Zayed, Rachel Maayan, Abraham Weizman, Vladimir Lerner |
Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 71
Issue 10
Pg. 1351-62
(Oct 2010)
ISSN: 1555-2101 [Electronic] United States |
PMID | 20584515
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © Copyright 2010 Physicians Postgraduate Press, Inc. |
Chemical References |
- Antipsychotic Agents
- Neurotransmitter Agents
- Dehydroepiandrosterone
- Pregnenolone
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Topics |
- Adolescent
- Adult
- Antipsychotic Agents
(administration & dosage)
- Attention
(drug effects)
- Dehydroepiandrosterone
(administration & dosage, adverse effects)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Therapy, Combination
(adverse effects)
- Dyskinesia, Drug-Induced
(drug therapy)
- Female
- Humans
- Male
- Memory, Short-Term
(drug effects)
- Middle Aged
- Neurotransmitter Agents
(administration & dosage, adverse effects)
- Pregnenolone
(administration & dosage, adverse effects)
- Psychotic Disorders
(drug therapy)
- Schizophrenia
(drug therapy)
- Severity of Illness Index
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