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

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ClinicalTrials.gov Identifier: NCT00560937
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : December 28, 2010
Last Update Posted : August 25, 2015
Sponsor:
Information provided by:
Durham VA Medical Center

Tracking Information
First Submitted Date  ICMJE November 19, 2007
First Posted Date  ICMJE November 20, 2007
Results First Submitted Date  ICMJE March 31, 2009
Results First Posted Date  ICMJE December 28, 2010
Last Update Posted Date August 25, 2015
Study Start Date  ICMJE June 2005
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2010)
  • Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048 [ Time Frame: SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) ]
    The SANS assesses negative symptoms in schizophrenia. The SANS consists of 21 clinical interview questions assessing negative symptoms of schizophrenia. Each question is rated on a scale of 0 (no symptoms) to 7 (severe symptoms).
  • Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS) [ Time Frame: Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) ]
    The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
  • Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) [ Time Frame: Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) ]
    The MATRICS is a battery for the assessment of cognitive symptoms in patients with schizophrenia. Composite T-scores are calculated (T-score ranges are -20 to +80, and are normed on gender and age). Higher scores are indicative of better cognitive performance, lower scores are indicative of poorer cognitive performance.
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2007)
BACS, MATRICS, SANS [ Time Frame: Prospective ]
Change History Complete list of historical versions of study NCT00560937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2010)
  • Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward) ]
    The CDSS is used measure to investigate depressive symptoms in schizophrenia. The measure includes 9 questions ranked from 0 (no symptoms) to 3 (severe symptoms). Range of possible scores: 0-27.
  • Clinical Global Impression Scale (CGI-I) [ Time Frame: CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward) ]
    The CGI-I is a commonly used psychiatric scale to assess overall general improvement. The CGI-I consists of one interviewer-rated question on a scale of 1-7. Lower scores are indicative of fewer symptoms; while higher scores are indicative of more symptoms.
  • Mean Score on the Positive and Negative Symptom Scale (PANSS) [ Time Frame: Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) ]
    The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2007)
CDSS, PANSS, CGI [ Time Frame: Prospective ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia
Official Title  ICMJE Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: 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
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Pregnenolone
    Intervention: Drug: Pregnenolone
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2007)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00560937
Other Study ID Numbers  ICMJE VA IRB# 00924
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christine E. Marx, MD, Durham Veterans Affairs Medical Center
Study Sponsor  ICMJE Durham VA Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christine E Marx, MD, MA Durham VAMC
PRS Account Durham VA Medical Center
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP