Overview

This trial is active, not recruiting.

Conditions schizophrenia, schizoaffective disorder
Treatments dietary supplement: pregnenolone, placebo
Phase phase 2
Sponsor VA Office of Research and Development
Start date December 2009
End date March 2015
Trial size 88 participants
Trial identifier NCT00728728, MHBB-012-07F, NCT00639886

Summary

This study will investigate adjunctive pregnenolone for cognitive symptoms and negative symptoms in patients with schizophrenia and schizoaffective disorder.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Pregnenolone
dietary supplement: pregnenolone
Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
(Placebo Comparator)
Placebo
placebo
Placebo

Primary Outcomes

Measure
MATRICS Consensus Cognitive Battery (MCCB)
time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
University of California Performance-based Skills Assessment (UPSA)
time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
Brief Assessment of Cognition in Schizophrenia (BACS)
time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
Scale for the Assessment of Negative Symptoms(SANS)
time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)

Secondary Outcomes

Measure
The Calgary Depression Scale for Schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS),Clinical Global Impressions (CGI) Scale
time frame: Prospective, outcome measures collected over 10 week trial period.
Positive and Negative Syndrome Scale (PANSS)
time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
Clinical Global Impressions (CGI) Scale
time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

Inclusion Criteria: - Diagnosis: DSM-IV/DSM-IV TR schizophrenia or schizoaffective disorder; - Gender: Males and Females; - Age: 21-65; - Caucasian or Non Caucasian; - Capable of providing informed consent; - Duration of illness equal to or greater than one year; - No change in antipsychotic medication in the previous eight weeks, no change in antipsychotic dose in the previous four weeks; - No benzodiazepine use in the past twelve hours prior to cognitive testing; - The patient cohort will be enriched for cognitive symptoms (Composite BACS scores = 0-3 standard deviations below the mean, assessed at the screening visit). Exclusion Criteria: - Subjects with a DSM-IV/DSM-IV TR diagnosis of alcohol or substance dependence (other than nicotine) within the last month; - Subjects with a history of significant head injury/trauma, as defined by one or more of the following: - Loss of consciousness (LOC) for more than 1 hour, - Recurring seizures resulting from the head injury, - Clear cognitive sequelae of the injury, - Cognitive rehabilitation following the injury; - Subjects with unstable medical illness or neurological illness (seizures, CVA); - Patients with hormone-sensitive tumors (such as breast, uterine, or prostate cancer); - Clinically significant abnormalities in physical examination , ECG, or laboratory assessments; - Pregnant women or women of child-bearing potential, who are either not surgically-sterile or not using appropriate methods of birth control (serum beta-human chorionic gonadotropin [HCG] will be performed at baseline, 4 weeks, and 8 weeks to exclude pregnancy); - Women who are breast-feeding; - Electroconvulsive therapy (ECT) treatment within the last 3 months; - Use of oral contraceptives or other hormonal supplementation such as estrogen. Although early studies suggested no effects on menstrual cycle, alterations in downstream metabolites of pregnenolone (such as estradiol) could theoretically impact the efficacy of oral contraceptives and/or estrogen replacement. Similarly, it is theoretically possible that pregnenolone could be metabolized to other steroids, resulting in hair, skin, or other steroid-related changes. Since we have determined in our prior study that pregnenolone administration does not result in downstream elevations in DHEA, DHEAS, estradiol, or testosterone, these possibilities may be unlikely; - Current active suicidal and/or homicidal ideation, intent, or plan; - Known allergy to study medication.

Additional Information

Official title Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia
Principal investigator Christine Marx, MD MA
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.