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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560937
First Posted: November 20, 2007
Last Update Posted: August 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Durham VA Medical Center
November 19, 2007
November 20, 2007
March 31, 2009
December 28, 2010
August 25, 2015
June 2005
April 2006   (Final data collection date for primary outcome measure)
  • 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.
BACS, MATRICS, SANS [ Time Frame: Prospective ]
Complete list of historical versions of study NCT00560937 on ClinicalTrials.gov Archive Site
  • 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.
CDSS, PANSS, CGI [ Time Frame: Prospective ]
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Not Provided
 
Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia
Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia
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.
See brief summary
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • Active Comparator: 1
    Pregnenolone
    Intervention: Drug: Pregnenolone
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
April 2008
April 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00560937
VA IRB# 00924
Not Provided
Not Provided
Not Provided
Christine E. Marx, MD, Durham Veterans Affairs Medical Center
Durham VA Medical Center
Not Provided
Principal Investigator: Christine E Marx, MD, MA Durham VAMC
Durham VA Medical Center
August 2015

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