A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Sildenafil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Donald C Goff, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital
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).
Clinical Details
Official title: A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Primary outcome: 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 speed, and executive function.
Secondary outcome: Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on psychotic, negative, and mood symptoms.Side effects of sildenafil 50 & 100 mg as self-reported by subjects and as measured with vital signs.
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 speed, and executive function.
2. Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on
psychotic, negative, and mood symptoms.
3. Assess self-reports of side effects of sildenafil 50 & 100 mg.
Location and Subjects:
25 adult outpatients with schizophrenia will be recruited from the Massachusetts General
Hospital outpatient clinic or the Freedom Trail Clinic of the Lindemann Center. All research
procedures will be performed at the Psychopharmacology Clinic of the Massachusetts General
Hospital. Subjects must be English speaking because the cognitive battery has only been
validated in English.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: February 2006
Ending date: September 2007
Last updated: December 14, 2007
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