Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

This study is currently recruiting participants.
Verified January 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00728728
First received: August 1, 2008
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Dietary Supplement: Pregnenolone
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • MATRICS, BACS, SANS [ Time Frame: Prospective, outcome measures collected over 10 week trial period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Outcome Measure: CDSS, PANSS, CGI [ Time Frame: Prospective, outcome measures collected over 10 week trial period. ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: December 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Pregnenolone
Drug: 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: Arm 2
Placebo
Dietary Supplement: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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-HCG will be performed at baseline, 4 weeks, and 8 weeks to exclude pregnancy);
  • Women who are breast-feeding;
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728728

Contacts
Contact: Trina Allen, MD (919) 286-0411 ext 7267 trina.allen@duke.edu
Contact: Christine Marx, MD MA (919) 286-0411 ext 5112 christine.marx@va.gov

Locations
United States, North Carolina
Durham VA Medical Center, Durham, NC Recruiting
Durham, North Carolina, United States, 27705
Contact: Christine Marx, MD MA    919-286-0411 ext 5112    christine.marx@va.gov   
Principal Investigator: Christine Marx, MD MA         
Sponsors and Collaborators
Investigators
Principal Investigator: Christine Marx, MD MA Durham VA Medical Center, Durham, NC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00728728     History of Changes
Obsolete Identifiers: NCT00639886
Other Study ID Numbers: MHBB-012-07F
Study First Received: August 1, 2008
Last Updated: January 22, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
pregnenolone
schizophrenia
cognitive
positive symptom
negative symptom
placebo control

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014