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

This study has been completed.
Sponsor:
Information provided by:
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00560937
First received: November 19, 2007
Last updated: December 29, 2010
Last verified: December 2010
  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.


Condition Intervention
Schizophrenia
Dietary Supplement: Pregnenolone
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 28
Study Start Date: June 2005
Study Completion Date: April 2008
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Pregnenolone
Dietary Supplement: 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
Placebo Comparator: 2
Placebo
Dietary Supplement: 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

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560937

Locations
United States, North Carolina
Durham VAMC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham Veterans Affairs Medical Center
Investigators
Principal Investigator: Christine E Marx, MD, MA Durham VAMC
  More Information

No publications provided

Responsible Party: Christine E. Marx, MD, Durham Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00560937     History of Changes
Other Study ID Numbers: VA IRB# 00924
Study First Received: November 19, 2007
Results First Received: March 31, 2009
Last Updated: December 29, 2010
Health Authority: United States: Food and Drug Administration
United States: Institional Review Board
United States: Federal Government

Keywords provided by Durham VA Medical Center:
Schizophrenia
Pregnenolone
Cognition
Negative Symptoms

Additional relevant MeSH terms:
Schizophrenia
Neurobehavioral Manifestations
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014