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

NCT ID: NCT00560937

Last Updated: 2015-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2008-04-30

Brief 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.

Detailed Description

See brief summary

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Pregnenolone

Group Type: ACTIVE_COMPARATOR

Pregnenolone

Intervention Type: DRUG

Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (similar to active comparator) 50 mg BID x 2 weeks, Placebo (similar to active comparator) 150 mg BID x 2 weeks, Placebo (similar to active comparator) 250 mg BID x 4 weeks

Interventions

Pregnenolone

Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks

Intervention Type: DRUG

Placebo

Placebo (similar to active comparator) 50 mg BID x 2 weeks, Placebo (similar to active comparator) 150 mg BID x 2 weeks, Placebo (similar to active comparator) 250 mg BID x 4 weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Durham VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Durham Veterans Affairs Medical Center

Principal Investigators

Christine E Marx, MD, MA

Role: PRINCIPAL_INVESTIGATOR

Durham VAMC

Locations

Durham VAMC

Durham, North Carolina, United States

Countries

United States

Other Identifiers

VA IRB# 00924

Identifier Type: -

Identifier Source: org_study_id