Schizophrenia Clinical Trial
Official title:
Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia: an 8-week, Randomized, Double-blind, Placebo-controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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