Schizophrenia
Conditions
Keywords
Schizophrenia, Pregnenolone, Neurosteroids
Brief summary
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.
Detailed description
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.
Interventions
DRUGPregnenolone
Sponsors
Beersheva Mental Health Center
Sha'ar Menashe Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* DSM-IV criteria for schizophrenia or schizoaffective disorder * Ability and willingness to sign informed consent for participation in the study
Exclusion criteria
* Evidence of organic brain damage, mental retardation, alcohol or drug abuse * Prostate nodules or cancer. * Moderate symptoms of benign prostatic hypertrophy such as hesitancy, urgency, frequent voiding and feeling of incomplete voiding. * History of ischemic cardiac disease. * Renal disease. * Hepatic dysfunction. * Women with a history of carcinoma of the breast, or any women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer. * Women with a history of uterine cancer. * Patients with a known hypersensitivity to androgens. * Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abnormal Involuntary Movement Scale. | — |
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Scale to assess Unawareness of Mental Disorder (SUMD, Amador, 1999). | — |
Countries
Israel
Outcome results
None listed