Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00728728
• Other study ID #: MHBB-012-07F
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 1, 2008
• Last updated: October 13, 2015
• Start date: December 2009
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will investigate adjunctive pregnenolone for cognitive symptoms and negative symptoms in patients with schizophrenia and schizoaffective disorder.

Other known NCT identifiers

• NCT00639886

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis: DSM-IV/DSM-IV TR schizophrenia or schizoaffective disorder;

• Gender: Males and Females;

• Age: 21-65;

• Caucasian or Non Caucasian;

• Capable of providing informed consent;

• Duration of illness equal to or greater than one year;

• No change in antipsychotic medication in the previous eight weeks, no change in antipsychotic dose in the previous four weeks;

• No benzodiazepine use in the past twelve hours prior to cognitive testing;

• The patient cohort will be enriched for cognitive symptoms (Composite BACS scores = 0-3 standard deviations below the mean, assessed at the screening visit).

Exclusion Criteria:

• Subjects with a DSM-IV/DSM-IV TR diagnosis of alcohol or substance dependence (other than nicotine) within the last month;

• Subjects with a history of significant head injury/trauma, as defined by one or more of the following:

• Loss of consciousness (LOC) for more than 1 hour,

• Recurring seizures resulting from the head injury,

• Clear cognitive sequelae of the injury,

• Cognitive rehabilitation following the injury;

• Subjects with unstable medical illness or neurological illness (seizures, CVA);

• Patients with hormone-sensitive tumors (such as breast, uterine, or prostate cancer);

• Clinically significant abnormalities in physical examination , ECG, or laboratory assessments;

• Pregnant women or women of child-bearing potential, who are either not surgically-sterile or not using appropriate methods of birth control (serum beta-human chorionic gonadotropin [HCG] will be performed at baseline, 4 weeks, and 8 weeks to exclude pregnancy);

• Women who are breast-feeding;

• Electroconvulsive therapy (ECT) treatment within the last 3 months;

• Use of oral contraceptives or other hormonal supplementation such as estrogen. Although early studies suggested no effects on menstrual cycle, alterations in downstream metabolites of pregnenolone (such as estradiol) could theoretically impact the efficacy of oral contraceptives and/or estrogen replacement. Similarly, it is theoretically possible that pregnenolone could be metabolized to other steroids, resulting in hair, skin, or other steroid-related changes. Since we have determined in our prior study that pregnenolone administration does not result in downstream elevations in DHEA, DHEAS, estradiol, or testosterone, these possibilities may be unlikely;

• Current active suicidal and/or homicidal ideation, intent, or plan;

• Known allergy to study medication.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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.

Dietary Supplement:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MATRICS Consensus Cognitive Battery (MCCB)	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.	Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)	No
Primary	University of California Performance-based Skills Assessment (UPSA)	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.	Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)	No
Primary	Brief Assessment of Cognition in Schizophrenia (BACS)	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).	Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)	No
Primary	Scale for the Assessment of Negative Symptoms(SANS)	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. Assessments are conducted on a six-point scale (0=not at all to 5=severe).[1]	Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)	No
Secondary	The Calgary Depression Scale for Schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS),Clinical Global Impressions (CGI) Scale	The CDSS assesses the level of depression in schizophrenia by measuring nine items on a 0 (absent) to 3 (severe) scale.	Prospective, outcome measures collected over 10 week trial period.	No
Secondary	Positive and Negative Syndrome Scale (PANSS)	The PANSS measures positive and negative symptoms of schizophrenia through administering a structured interview. After the interview, 25 PANSS items are rated 1 (absent) to 7 (extreme). These items are organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation.	Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)	No
Secondary	Clinical Global Impressions (CGI) Scale	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.	Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)	No