N/A N=21 Randomized Quadruple-blind Treatment

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

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00560937 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2010

Primary outcome: Primary: Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048 — -10.38; -2.33 units on a scale — p=.048

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pregnenolone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Durham VA Medical Center
Primary completion: Apr 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048	-10.38; -2.33	.048 sig
PRIMARY Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)	0.60; 0.22	0.22
PRIMARY Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)	7.00; 7.00	1.0
SECONDARY Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS)	-1.57; -2.00	0.79
SECONDARY Clinical Global Impression Scale (CGI-I)	2.11; 2.89	0.014 sig
SECONDARY Mean Score on the Positive and Negative Symptom Scale (PANSS)	-9.88; -5.44	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00560937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.