Repository of Research and Investigative Information

Repository of Research and Investigative Information

Kurdistan University of Medical Sciences

Pregnenolone as an adjunct to risperidone for treatment of women with schizophrenia: A randomized double-blind placebo-controlled clinical trial

(2017) Pregnenolone as an adjunct to risperidone for treatment of women with schizophrenia: A randomized double-blind placebo-controlled clinical trial. Journal of Psychiatric Research.

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Official URL: https://www.scopus.com/inward/record.uri?eid=2-s2....

Abstract

There have been few studies of pregnenolone therapy in schizophrenia and those that exist have been subject to several critical limitations, thus yielding inconsistent results. We attempted to assess the therapeutic effect of pregnenolone in a patient sample as homogeneous as possible. In this randomized double-blind clinical trial, 82 female inpatients with chronic schizophrenia, who had discontinued their antipsychotic medications for at least one week in case of any oral antipsychotic medication or a month for any depot antipsychotic medication, received risperidone plus either pregnenolone (50 mg/day) or placebo for 8 weeks. Inclusion criteria were acute illness with a baseline Positive and Negative Syndrome Scale (PANSS) negative subscale score of ≥20. Exclusion criteria were the presence of severe depression or other concomitant psychiatric disorders. Primary outcome was defined as the difference in the PANSS total score change from baseline to week 8 in the pregnenolone group compared to the placebo group. No significant difference was found in the PANSS total score changes between the two arms (mean difference (CI 95) = −9.41 (−20.24 to 1.41); p = 0.087). Significant differences were initially found for PANSS negative change scores (mean difference (CI 95) = −2.61 (−5.03 to −0.19); p = 0.035) and general psychopathology change scores (mean difference (CI 95) = −5.93 (−11.37 to −0.48); p = 0.033). However, these findings did not survive Bonferroni correction for multiple testing. While this trial may suggest a potential effect of pregnenolone on schizophrenia symptoms, further studies are warranted. © 2017 Elsevier Ltd

Item Type: Article
Keywords: clozapine; fluphenazine; haloperidol; olanzapine; placebo; pregnenolone; risperidone, acne; add on therapy; Article; combination drug therapy; constipation; controlled study; diarrhea; dizziness; double blind procedure; drowsiness; elevated blood pressure; extrapyramidal symptom; female; hair growth; headache; health; hospital patient; human; increased appetite; insomnia; major clinical study; male; maximum permissible dose; mental patient; nausea; negative syndrome; patient history of therapy; Positive and Negative Syndrome Scale; positive syndrome; priority journal; psychopharmacotherapy; randomized controlled trial; schizophrenia; side effect; vomiting; xerostomia
Page Range: pp. 70-77
Journal or Publication Title: Journal of Psychiatric Research
Volume: 94
Publisher: Elsevier Ltd
Identification Number: 10.1016/j.jpsychires.2017.06.011
ISSN: 00223956
Depositing User: مهندس مهدی شریفی
URI: http://eprints.muk.ac.ir/id/eprint/161

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