Pregnenolone treatment reduces severity of negative symptoms in recent‐onset schizophrenia: An 8‐week, double‐blind, randomized add‐on two‐center trial

Aims Management of recent‐onset schizophrenia (SZ) and schizoaffective disorder (SA) is challenging owing to frequent insufficient response to antipsychotic agents. This study aimed to test the efficacy and safety of the neurosteroid pregnenolone in patients with recent‐onset SZ/SA. Methods Sixty ou...

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Bibliographic Details
Published in:	Psychiatry and clinical neurosciences Vol. 68; no. 6; pp. 432 - 440
Main Authors:	Ritsner, Michael S., Bawakny, Hisham, Kreinin, Anatoly
Format:	Journal Article
Language:	English
Published:	Australia Wiley Subscription Services, Inc 01-06-2014
Subjects:	Adolescent Adult Anti-Inflammatory Agents - adverse effects Anti-Inflammatory Agents - therapeutic use Antipsychotic Agents - therapeutic use clinical trial Diagnostic and Statistical Manual of Mental Disorders Double-Blind Method Drug Therapy, Combination Female Humans Male pregnenolone Pregnenolone - adverse effects Pregnenolone - therapeutic use recent‐onset schizophrenia schizoaffective disorder Schizophrenia - drug therapy Schizophrenic Psychology Treatment Outcome Young Adult clinical trial recent-onset schizophrenia pregnenolone schizoaffective disorder
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Summary:	Aims Management of recent‐onset schizophrenia (SZ) and schizoaffective disorder (SA) is challenging owing to frequent insufficient response to antipsychotic agents. This study aimed to test the efficacy and safety of the neurosteroid pregnenolone in patients with recent‐onset SZ/SA. Methods Sixty out‐ and inpatients who met DSM‐IV criteria for SZ/SA, with suboptimal response to antipsychotics were recruited for an 8‐week, double‐blind, randomized, placebo‐controlled, two‐center add‐on trial, that was conducted between 2008 and 2011. Participants were randomized to receive either pregnenolone (50 mg/day) or placebo added on to antipsychotic medications. The primary outcome measures were the Positive and Negative Symptoms Scale and the Assessment of Negative Symptoms scores. Secondary outcomes included assessments of functioning, and side‐effects. Results Analysis was by linear mixed model. Fifty‐two participants (86.7%) completed the trial. Compared to placebo, adjunctive pregnenolone significantly reduced Positive and Negative Symptoms Scale negative symptom scores with moderate effect sizes (d = 0.79). Significant improvement was observed in weeks 6 and 8 of pregnenolone therapy among patients who were not treated with concomitant mood stabilizers (arms × visit × mood stabilizers; P = 0.010). Likewise, pregnenolone significantly reduced Assessment of Negative Symptoms scores compared to placebo (d = 0.57), especially on blunted affect, avolition and anhedonia domain scores. Other symptoms, functioning, and side‐effects were not significantly affected by adjunctive pregnenolone. Antipsychotic agents, benzodiazepines and sex did not associate with pregnenolone augmentation. Pregnenolone was well tolerated. Conclusions Thus, add‐on pregnenolone reduces the severity of negative symptoms in recent‐onset schizophrenia and schizoaffective disorder, especially among patients who are not treated with concomitant mood stabilizers. Further studies are warranted.
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ISSN:	1323-1316 1440-1819
DOI:	10.1111/pcn.12150