Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455715
Status:
COMPLETED
Last Update Posted:
2011-06-29
First Post:
2007-04-02
Brief Title:
A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None