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

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00455715
First received: April 2, 2007
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Schizophrenia
 Drug: Sildenafil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on psychotic, negative, and mood symptoms. [ Time Frame: 12 days ] [ Designated as safety issue: No ]
  • Side effects of sildenafil 50 & 100 mg as self-reported by subjects and as measured with vital signs. [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: February 2006
Study Completion Date: September 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sildenafil
    1 capsule Sildenafil 50mg or Sildenafil 100mg or placebo taken at the time of study visit.
    Other Name: Viagra
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455715

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Donald C Goff, M.D. Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Donald Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00455715     History of Changes
Other Study ID Numbers: 2005-P-000529
Study First Received: April 2, 2007
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Schizophrenia
Cognition
Sildenafil
PDE5 Inhibitor

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Sildenafil
Vasodilator Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013