Pregnenolone in the Management of Schizophrenia Patients
Pregnenolone is a "neurosteroid" and possesses intrinsic behavioral and brain effects in animals, affecting the GABA(A) and other receptors. Pregnenolone is serves as the precursor for dehydroepiandrosterone (DHEA) and its sulfate ester (DHEAS). There is evidence of efficacy of DHEA augmentation in schizophrenia, we therefore sought to examine the efficacy of augmentation of antipsychotic treatment of schizophrenia patients with pregnenolone. It is hypothesized that the combined effect of antipsychotic agents and pregnenolone would be beneficial in the treatment of negative,depressive, and cognitive symptoms.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Pregnenolone Augmentation in the Management of Schizophrenia Patients: a Randomised Double-Blind Placebo-Controlled Trial|
- The computerized Cambridge Neuropsychological Test Automated Battery (CANTAB).
- The Positive and Negative Syndrome Scale.
- The Scale for the Assessment of Negative Symptoms.
- The Calgary Depression Scale for Schizophrenia.
- The Hamilton Scale for Anxiety.
- Extrapyramidal Symptom Rating Scale.
- Barnes Akathisia Scale.
- Abnormal Involuntary Movement Scale.
- The Scale to assess Unawareness of Mental Disorder (SUMD, Amador, 1999).
|Study Start Date:||January 2005|
|Study Completion Date:||May 2007|
Either pregnenolone (30 mg/d or 200 mg/d), DHEA (400 mg/d)or placebo will be added to regular treatment for 8 weeks. Subjects will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. An extensive battery of research instruments will be used for assessment of the following domains of interest: psychopathology, insight, side effects, and cognitive functions. Plasma pregnenolone, DHEA(S), cortisol and other relevant steroids will be assayed at baseline, 2, 4, 6 and 8 weeks of treatment. Efficacy and safety of augmentation of antipsychotic treatment with pregnenolone will be analyzed.
|Sha'ar Menashe Mental Health|
|Hadera, Israel, 38814|
|Principal Investigator:||Michael S. Ritsner, MD, PhD||Sha’ar Menashe Mental Health Center|