NCT00455715

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

1.6 years

First QC Date

April 2, 2007

Last Update Submit

June 27, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaCognitionSildenafilPDE5 Inhibitor

Outcome Measures

Primary Outcomes (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.

    12 days

Secondary Outcomes (2)

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

    12 days

  • Side effects of sildenafil 50 & 100 mg as self-reported by subjects and as measured with vital signs.

    12 days

Interventions

SildenafilDRUG

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

Also known as: Viagra

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 18716761RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Donald C Goff, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 4, 2007

Study Start

February 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2008

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations

US(1)