Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Durham, North Carolina 27705


Purpose:

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.


Study summary:

See brief summary


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.


NCT ID:

NCT00560937


Primary Contact:

Principal Investigator
Christine E Marx, MD, MA
Durham VAMC


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27705
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.