Clinical trial NCT00560937: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Pregnenolone
Cognition
Negative Symptoms
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
First posted: 2007-11-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048
timeFrame: SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
measure: Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)
timeFrame: Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
measure: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
timeFrame: Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
Secondary outcomes:
measure: Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward)
measure: Clinical Global Impression Scale (CGI-I)
timeFrame: CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
measure: Mean Score on the Positive and Negative Symptom Scale (PANSS)
timeFrame: Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VAMC
state: North Carolina
Study officials:
affiliation: Durham VAMC
name: Christine E Marx, MD, MA
role: PRINCIPAL_INVESTIGATOR
References: