Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia

Durham VA Medical Center

Status

Completed

Conditions

Schizophrenia

Treatments

Drug: Pregnenolone

Drug: Placebo

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00560937

VA IRB# 00924

Details and patient eligibility

About

This is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. The goal of this placebo-controlled study is to provide preliminary efficacy data for potential pregnenolone effects on cognitive symptoms and negative symptoms in patients with schizophrenia. Depressive symptoms and positive symptoms will also be assessed.

Full description

See brief summary

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18-65 years of age, any ethnic group, either sex
Diagnostic and Statistical Manual, 4th edition (DSM IV) diagnosis of schizophrenia or schizoaffective disorder
Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.
Patient cohort enriched for moderate to severe cognitive symptoms (composite Brief Assessment of Cognition in Schizophrenia (BACS) score 0-3 SD below the mean).
No change in antipsychotic for 8 weeks or longer. No change in antipsychotic dose for 4 weeks or longer.
No change in anticholinergic, benzodiazepine, or mood stabilizer medications for 4 weeks or longer.
No anticipated need to alter any of the above medications (antipsychotics, anticholinergics, benzodiazepines, or mood stabilizers) for the 10-week duration of the study.

Exclusion criteria

Unstable medical illness or neurologic illness (seizures, cerebrovascular accident); history of prostate, breast, uterine, or ovarian cancer.
Use of oral contraceptives or other hormonal supplementation such as estrogen.
Other concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
Active expression of suicidal or homicidal ideation.
Comorbid substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.
Female patients who are pregnant or breast-feeding.
Known allergy to study medication.
Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc) will be excluded as suggested by the Federal Drug Administration (FDA); patients taking these agents will not be eligible for this study.