SchizophreniaPhase 4NCT00455715
A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia
A Phase 4 study testing Sildenafil in people with Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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:
- 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.
- Conditions
- Schizophrenia
- Being tested
- Sildenafil
- Keywords
- Schizophrenia, Cognition, Sildenafil, PDE5 Inhibitor
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Viagra
1 capsule Sildenafil 50mg or Sildenafil 100mg or placebo taken at the time of study visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 days
Side effects of sildenafil 50 & 100 mg as self-reported by subjects and as measured with vital signs.
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startFeb 2006
- Primary completionSep 2007
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Donald C Goff, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455715
- Sponsor's protocol ID
- 2005-P-000529
- Status last verified
- Jun 2011
- First submitted
- 2 Apr 2007
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia
- ClinicalTrials.gov ID
- NCT00455715
- Acronym / sponsor ID
- 2005-P-000529
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Cognition, Sildenafil, PDE5 Inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilAlso: Viagra1 capsule Sildenafil 50mg or Sildenafil 100mg or placebo taken at the time of study visit. | Drug | – |
Primary outcome
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
2 secondary outcomes
Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on psychotic, negative, and mood symptoms.
Time frame: 12 days
Side effects of sildenafil 50 & 100 mg as self-reported by subjects and as measured with vital signs.
Time frame: 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
- Results publication: PubMed 18716761Goff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald C Goff, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil in people with Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00455715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.