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

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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.