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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cognition, Sildenafil, PDE5 Inhibitor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Outcomes

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 2, 2007
Last Updated
June 27, 2011
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00455715
Brief Title
A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia
Official Title
A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Cognition, Sildenafil, PDE5 Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Viagra
Intervention Description
1 capsule Sildenafil 50mg or Sildenafil 100mg or placebo taken at the time of study visit.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on psychotic, negative, and mood symptoms.
Time Frame
12 days
Title
Side effects of sildenafil 50 & 100 mg as self-reported by subjects and as measured with vital signs.
Time Frame
12 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald C Goff, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18716761
Citation
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. doi: 10.1007/s00213-008-1278-5. Epub 2008 Aug 21.
Results Reference
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A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia

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