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

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: April 2006

Detailed Clinical Trial Description

See brief summary

Interventions Used in this Clinical Trial

  • 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
  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Pregnenolone
  • Placebo Comparator: 2
    • Placebo

Outcome Measures for this Clinical Trial

Primary 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)
      Safety Issue?: No
  • 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)
      Safety Issue?: No
  • 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)
      Safety Issue?: No

Secondary 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)
      Safety Issue?: No
  • Clinical Global Impression Scale (CGI-I)
    • Time Frame: CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
      Safety Issue?: No
  • 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)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Durham Veterans Affairs Medical Center
  • Provider of Information About this Clinical Study
    • Christine E. Marx, MD, Durham Veterans Affairs Medical Center
  • Overall Official(s)
    • Christine E Marx, MD, MA, Principal Investigator, Durham VAMC

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00560937