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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
History of Changes
Results First Received: March 31, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Dietary Supplement: Pregnenolone
Dietary Supplement: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient recruitment occurred between 8-05 and 4-06 for this single-site study at the Durham VAMC, Durham, NC.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following the screening visit, patients were withdrawn during the placebo lead-in phase and were not randomized for the following reasons: 1. hyponatremia, 2. hospitalization, 3.pneumonia, 4.no show for follow-up study visit, 5.chest pain, 6. elevated prolactin at baseline, 7.prolonged QTc at baseline

Reporting Groups
  Description
Pregnenolone
  • Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
  • Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
  • Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks.
Placebo Placebo dosing and tablets were identical to Pregnenolone.

Participant Flow:   Overall Study
    Pregnenolone     Placebo  
STARTED     10     11  
COMPLETED     9 [1]   9  
NOT COMPLETED     1     2  
Withdrawal by Subject                 0                 1  
Physician Decision                 1                 1  
[1] One participant was withdrawn after 6 weeks and data were carried forward



  Baseline Characteristics
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Reporting Groups
  Description
Pregnenolone
  • Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
  • Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
  • Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks.
Placebo Placebo dosing and tablets were identical to Pregnenolone.
Total Total of all reporting groups

Baseline Measures
    Pregnenolone     Placebo     Total  
Number of Participants  
[units: participants]
 		  10     11     21  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     10     11     21  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  53  ± 6     49  ± 12     51  ± 9  
Gender  
[units: participants]
 		     
Female     1     1     2  
Male     9     10     19  
Region of Enrollment  
[units: participants]
 		     
United States     10     11     21  



  Outcome Measures
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1.  Primary:   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) ]
  Show Outcome Measure 1

2.  Primary:   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) ]
  Hide Outcome Measure 2

Measure Type Primary
Measure Title Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Pregnenolone
  • Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
  • Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
  • Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks.
Placebo Placebo dosing and tablets were identical to Pregnenolone.

Measured Values
    Pregnenolone     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  9     9  
Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)  
[units: units on a scale]
Mean ± Standard Deviation 		  0.60  ± 0.78     0.22  ± 0.47  


Statistical Analysis 1 for Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)
Groups [1] Placebo
Method [2] t-test, 2 sided
P Value [3] 0.22
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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3.  Primary:   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) ]
  Show Outcome Measure 3

4.  Secondary:   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) ]
  Show Outcome Measure 4

5.  Secondary:   Clinical Global Impression Scale (CGI-I)   [ Time Frame: CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward) ]
  Show Outcome Measure 5

6.  Secondary:   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) ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Christine E. Marx, MD, MA
Organization: Durham Veterans Affairs Medical Center
phone: 919 286-0411 ext 7426
e-mail: marx0001@mc.duke.edu


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