A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00455715

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Memory Psychotic Disorders Schizophrenia

Drug Information available for: Sildenafil Sildenafil citrate

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:

1 capsule Sildenafil 50mg or Sildenafil 100mg or placebo taken at the time of study visit.

Detailed Description:

Specific Aims:

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.
Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on psychotic, negative, and mood symptoms.
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:

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 Criteria:

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

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:

Goff DC, Cather C, Freudenreich O, Henderson DC, Evins AE, Culhane MA, Walsh JP. A placebo-controlled study of sildenafil effects on cognition in schizophrenia. Psychopharmacology (Berl). 2009 Jan;202(1-3):411-7. Epub 2008 Aug 21.

Responsible Party:	Massachusetts General Hospital ( Donald Goff, MD )
Study ID Numbers:	2005-P-000529
Study First Received:	April 2, 2007
Last Updated:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00455715 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Schizophrenia
Cognition
Sildenafil
PDE5 Inhibitor

Study placed in the following topic categories:

Schizophrenia
Vasodilator Agents
Phosphodiesterase Inhibitors
Mental Disorders

Sildenafil
Psychotic Disorders
Cardiovascular Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Mental Disorders
Therapeutic Uses

Enzyme Inhibitors
Sildenafil
Cardiovascular Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 10, 2009