Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia

Summary

Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the central nervous system, and may be beneficial in the treatment of patients with schizophrenia. Our recent 8-week, randomized, double-blind trial among patients with chronic schizophrenia and schizoaffective disorders, in which PREG versus placebo and DHEA have been added to conventional or atypical antipsychotics have yielded encouraging results with low-dose PREG (30 mg/day; ClinicalTrials.gov identifier NCT00140192; Ritsner et al., in press). The goal of the present study is to evaluate the potential role of PREG's augmentation compared to placebo in the treatment of young patients with newly diagnosed schizophrenia or schizophreniform or schizoaffective disorders.

In a 8-week, randomized, double-blind placebo-controlled trial PREG (50 mg/day) or placebo capsules will be added to the stable ongoing antipsychotic treatment of 60 patients with recent-onset schizophrenia or schizophreniform or schizoaffective disorders. Participants will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of research instruments will be used for assessment of psychopathology, cognitive functions, side effects, general functioning and quality of life. In addition blood PREG levels will be monitored at baseline and during the study. The study is powered to detect moderate between-group effects on persistent positive, negative and cognitive symptoms.

Conditions

• Schizophrenia
• Schizophreniform Disorder
• Schizoaffective Disorders

Interventions

DIETARY_SUPPLEMENT

Pregnenolone

50 mg, caps.

DIETARY_SUPPLEMENT

Placebo

caps

Sponsors & Collaborators

• Tirat Carmel Mental Health Center

  collaborator OTHER_GOV

• Sha'ar Menashe Mental Health Center

  lead OTHER

Principal Investigators

• Michael S Ritsher, MD, PhD · Technion and Shaar Menashe MHC

• Anatoly Kreinin, MD, PhD · Technion and Tirat Carmel Mental Health Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2010-12-31

Completion

2010-12-31

Countries

• Israel

Study Locations