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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pregnenolone
Placebo
Sponsored by
Durham VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Pregnenolone, Cognition, Negative Symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Durham VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Pregnenolone

Placebo

Outcomes

Primary Outcome Measures

Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048
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)
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)
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)
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)
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)
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.

Full Information

First Posted
November 19, 2007
Last Updated
August 11, 2015
Sponsor
Durham VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00560937
Brief Title
Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia
Official Title
Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Durham VA Medical Center

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Pregnenolone, Cognition, Negative Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pregnenolone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Pregnenolone
Intervention Description
Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048
Description
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).
Time Frame
SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
Title
Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)
Description
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.
Time Frame
Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
Title
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Description
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.
Time Frame
Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
Secondary Outcome Measure Information:
Title
Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS)
Description
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.
Time Frame
Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward)
Title
Clinical Global Impression Scale (CGI-I)
Description
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.
Time Frame
CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
Title
Mean Score on the Positive and Negative Symptom Scale (PANSS)
Description
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.
Time Frame
Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years of age, any ethnic group, either sex Diagnostic and Statistical Manual, 4th edition (DSM IV) diagnosis of schizophrenia or schizoaffective disorder Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process. Patient cohort enriched for moderate to severe cognitive symptoms (composite Brief Assessment of Cognition in Schizophrenia (BACS) score 0-3 SD below the mean). No change in antipsychotic for 8 weeks or longer. No change in antipsychotic dose for 4 weeks or longer. No change in anticholinergic, benzodiazepine, or mood stabilizer medications for 4 weeks or longer. 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: Unstable medical illness or neurologic illness (seizures, cerebrovascular accident); history of prostate, breast, uterine, or ovarian cancer. Use of oral contraceptives or other hormonal supplementation such as estrogen. Other concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary. Active expression of suicidal or homicidal ideation. Comorbid substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician. Female patients who are pregnant or breast-feeding. Known allergy to study medication. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine E Marx, MD, MA
Organizational Affiliation
Durham VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VAMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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

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