Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia (PREG-2008)
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|ClinicalTrials.gov Identifier: NCT00847600|
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : December 15, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizophreniform Disorder Schizoaffective Disorders||Dietary Supplement: Pregnenolone Dietary Supplement: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia: an 8-week, Randomized, Double-blind, Placebo-controlled Trial|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: 1 Pregnenolone
Dietary Supplement: Pregnenolone
50 mg, caps.
Placebo Comparator: 2 Placebo
Dietary Supplement: Placebo
- The Clinical Global Impression Scale (CGI-S) The Positive and Negative Syndrome Scale (PANSS) The Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: baseline, 2, 4, 6, and 8 weeks ]
- Global Assessment of Functioning [ Time Frame: baseline, 2, 4, 6, and 8 weeks ]
- The Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: baseline, 4 and 8 weeks ]
- Extrapyramidal Symptom Rating Scale [ Time Frame: baseline, 2, 4, 6, and 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847600
|Shaar Menashe MHC and Tirat Carmel MHC|
|Hadera, Israel, 38814|
|Study Chair:||Michael S Ritsher, MD, PhD||Technion and Shaar Menashe MHC|
|Study Director:||Anatoly Kreinin, MD, PhD||Technion and Tirat Carmel Mental Health Center|