Status:
COMPLETED
Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia
Lead Sponsor:
Sha'ar Menashe Mental Health Center
Collaborating Sponsors:
Tirat Carmel Mental Health Center
Conditions:
Schizophrenia
Schizophreniform Disorder
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
Brief 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, randomiz...
Eligibility Criteria
Inclusion
- 18-40 years of age, any ethnic group, either sex.
- DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorders (36).
- Duration of illness less than 5 years since onset first psychotic episode.
- Subjects entering the study must score at least 4 on the Clinical Global Impression Scale.
- At least two weeks of ongoing treatment with current antipsychotic agents during the pre-treatment stabilization period.
- Stable symptoms throughout the 2-week pre-treatment stabilization period. Clinical stability is defined as two consecutive weekly CGI ratings with no change in score, and with no more than a 20% change in PANSS total score.
- No change in anticholinergic, benzodiazepine, or mood stabilizer medications for the pre-treatment stabilization period.
- No anticipated need to alter any of the above medications (antipsychotics, anticholinergics, benzodiazepines, or mood stabilizers) for the 8-week duration of the study.
- Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.
Exclusion
- Evidence of serious neurologic or endocrine disorder, for example severe head trauma, seizure disorder, dementia, Cushings disease, or thyroid disorder, mental retardation, alcohol or drug abuse, substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.
- Unstable medical illness or neurologic illness (seizures, CVA); history of prostate, breast, uterine, or ovarian cancer.
- Pregnant women, use of oral contraceptives or other hormonal supplementation such as estrogen.
- Current active suicidal and/or homicidal ideation, intent, or plan.
- Known allergy to study medication.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00847600
Start Date
March 1 2009
End Date
December 1 2010
Last Update
December 15 2010
Active Locations (1)
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1
Shaar Menashe MHC and Tirat Carmel MHC
Hadera, Israel, 38814