A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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 whether this PDE5 inhibitor improves cognitive functioning (including verbal memory, fluency, attention, spatial memory, motor speed, and executive function) and clinical symptoms (psychotic, negative, mood symptoms, and self-reports of side-effects).

Key facts

Study ID

NCT00455715

Run by

Massachusetts General Hospital

People needed

18

Starts

2006-02-01

Expected to finish

2008-09-01

Last updated by the study team

2011-06-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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