Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia
|Schizophrenia Schizoaffective Disorder||Drug: Dietary Supplement: Pregnenolone Dietary Supplement: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia|
- MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) ]
The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition.
The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance.
- University of California Performance-based Skills Assessment (UPSA) [ Time Frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) ]The UCSD Performance-based Skills Assessment (UPSA) is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains (comprehension and planning, finance, communication, mobility and house management) when combined, measures functional capacity. The comprehension and planning subdomain ranges from 0 to 14, the finance subdomain ranges from 0 to 11, the communication subdomain ranges from 0 to 12, the mobility subdomain ranges from 0 to 9, and the house management subdomain ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance.
- Brief Assessment of Cognition in Schizophrenia (BACS) [ Time Frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) ]The Brief Assessment of Cognition in Schizophrenia (BACS) captures those domains of cognition that are the most severely affected in patients with schizophrenia and the most strongly correlated with functional outcome. The domains of cognitive function assessed and the associated tests include: Verbal Memory & Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London). These domains are then converted to Z scores compared to standardized scoring scales, with higher scores representing better performance.
- Scale for the Assessment of Negative Symptoms(SANS) [ Time Frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) ]The Scale for the Assessment of Negative Symptoms (SANS) is an assessment used to obtain clinical ratings of negative symptoms in patients with schizophrenia. The SANS assesses five symptom complexes. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. 24 assessments are conducted on a six-point scale (0=not at all to 5=severe) each, for a total scoring range of 0-120. Lower scores represent better performance.
- The Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Prospective, outcome measures collected over 10 week trial period. ]The CDSS assesses the level of depression in schizophrenia by measuring nine items on a 0 (absent) to 3 (severe) scale each. Thus, the total score range is 0 to 27. Lower scores represent better outcomes.
- Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) ]The PANSS measures positive and negative symptoms of schizophrenia through administering a structured interview. After the interview, 25 PANSS items are each rated 1 (absent) to 7 (extreme). These items are organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The combination of the 25 items produces a total score range of 25-175, and lower scores represent better outcomes.
- Clinical Global Impressions (CGI) Scale [ Time Frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) ]The CGI scale provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises two companion one-item measures evaluating the severity of psychopathology from 1 to 7 and change from the initiation of treatment on a similar seven-point scale. Thus, scores range from 2 to 14, with lower scores representing better outcomes.
|Study Start Date:||December 2009|
|Study Completion Date:||December 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1: Pregnenolone
Drug: Dietary Supplement: Pregnenolone
Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
Placebo Comparator: Arm 2: Placebo
Dietary Supplement: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728728
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Christine Marx, MD MA||Durham VA Medical Center, Durham, NC|