Status:
COMPLETED
A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The study is a double-blind, placebo-controlled, random-order, single-dose crossover trial of sildenafil 50 \& 100 mg added to stable antipsychotic treatment in schizophrenia patients to assess whethe...
Detailed Description
Specific Aims: 1. Evaluate the effects of single doses of sildenafil 50 \& 100 mg compared to placebo on cognitive functioning, including verbal memory, fluency, attention, spatial memory, motor spee...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia, any subtype.
- Age 18-65 years
- Male or female
- Clinically stable without a medication change within 4 weeks
- Able to complete cognitive testing (must be English-speaking)
- Willing to use appropriate birth control during study participation (if female)
Exclusion
- Active substance abuse or dependence
- PDE 5 inhibitor taken within 24 hours of study drug
- Currently taking a drug that inhibits hepatic cytochrome P450 3A4 (eg. Nefazadone, fluvoxamine, erythromycin, ketoconazole, itraconazole, cimetidine, saquinavir, ritonavir, St. John's wort, or grapefruit juice).
- Currently taking drugs that induce P45 3A4 (eg. phenytoin, carbamezapine, Phenobarbital, rifampin)
- Unstable medical disease
- Significant cardiac disease
- Bleeding disorder
- Peptic ulcer disease
- Hepatic impairment
- Moderate or greater renal impairment
- History of migraines
- Currently taking nitrates or alpha blockers
- Resting blood pressure \< 90/50 or \>140/90 mm.
- History of intolerance to PDE5 inhibitors
- History of inappropriate sexual behavior (eg, masturbation in public, stalking, assault)
- History of priapism
- Pregnant or lactating
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00455715
Start Date
February 1 2006
End Date
September 1 2008
Last Update
June 29 2011
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114