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Pregnenolone treatment reduces severity of negative symptoms in recent‐onset schizophrenia: An 8‐week, double‐blind, randomized add‐on two‐center trial
Author(s) -
Ritsner Michael S.,
Bawakny Hisham,
Kreinin Anatoly
Publication year - 2014
Publication title -
psychiatry and clinical neurosciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.609
H-Index - 74
eISSN - 1440-1819
pISSN - 1323-1316
DOI - 10.1111/pcn.12150
Subject(s) - pregnenolone , placebo , schizophrenia (object oriented programming) , randomized controlled trial , medicine , anhedonia , psychology , scale for the assessment of negative symptoms , antipsychotic , psychiatry , psychosis , negative symptom , steroid , alternative medicine , pathology , hormone
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.