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CompletedNCT00455715Updated Jun 29, 2011

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

A Phase 4 interventional study of Sildenafil in Schizophrenia, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-06-29.

Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Schizophrenia

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Keywords

  • Schizophrenia
  • Cognition
  • Sildenafil
  • PDE5 Inhibitor
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 18 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Interventions

  • DrugSildenafil

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

    Also known as: Viagra

06

What researchers measure

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.

    Time frame: 12 days

Secondary outcomes

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

    Time frame: 12 days

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

    Time frame: 12 days

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

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. doi: 10.1007/s00213-008-1278-5. Epub 2008 Aug 21. PubMed 18716761 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00455715
Lead sponsor
Massachusetts General Hospital
First posted
Apr 4, 2007
Start date
Feb 2006
Primary completion
Sep 2007
Completion
Sep 2008
Last update
Jun 29, 2011

Study contacts

Donald C Goff, M.D.
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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