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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

1. Diagnosis of schizophrenia, any subtype.

2. Age 18-65 years

3. Male or female

4. Clinically stable without a medication change within 4 weeks

5. Able to complete cognitive testing (must be English-speaking)

6. Willing to use appropriate birth control during study participation (if female)

Exclusion Criteria:

1. Active substance abuse or dependence

2. PDE 5 inhibitor taken within 24 hours of study drug

3. 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).

4. Currently taking drugs that induce P45 3A4 (eg. phenytoin, carbamezapine, Phenobarbital, rifampin)

5. Unstable medical disease

6. Significant cardiac disease

7. Bleeding disorder

8. Peptic ulcer disease

9. Hepatic impairment

10. Moderate or greater renal impairment

11. History of migraines

12. Currently taking nitrates or alpha blockers

13. Resting blood pressure < 90/50 or >140/90 mm.

14. History of intolerance to PDE5 inhibitors

15. History of inappropriate sexual behavior (eg, masturbation in public, stalking, assault)

16. History of priapism

17. Pregnant or lactating