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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Durham VA Medical Center

Criteria

Inclusion Criteria:

1. 18-65 years of age, any ethnic group, either sex

2. Diagnostic and Statistical Manual, 4th edition (DSM IV) diagnosis of schizophrenia or schizoaffective disorder

3. Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.

4. Patient cohort enriched for moderate to severe cognitive symptoms (composite Brief Assessment of Cognition in Schizophrenia (BACS) score 0-3 SD below the mean).

5. No change in antipsychotic for 8 weeks or longer. No change in antipsychotic dose for 4 weeks or longer.

6. No change in anticholinergic, benzodiazepine, or mood stabilizer medications for 4 weeks or longer.

7. 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:

1. Unstable medical illness or neurologic illness (seizures, cerebrovascular accident); history of prostate, breast, uterine, or ovarian cancer.

2. Use of oral contraceptives or other hormonal supplementation such as estrogen.

3. Other concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.

4. Active expression of suicidal or homicidal ideation.

5. Comorbid substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.

6. Female patients who are pregnant or breast-feeding.

7. Known allergy to study medication.

8. 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.