Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455702
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2007-04-02
Brief Title:
Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals
Status:
COMPLETED
Status Verified Date:
2014-07
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 aims to assess the effects of single dose and repeated weekly dosing of 50mg d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients The study will also examine the effects of 50mg d-cycloserine on positive symptoms and negative symptoms as well as assess tolerability and side-effects
Detailed Description:
This is a ten-week parallel-group placebo-controlled trial examining the cognitive effects at weeks 1 2 3 4 5 6 7 8 10 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in 60 adult outpatients with schizophrenia
Specific aims
1 Assess the effects of a single dose of D-cycloserine 50 mg on cognitive functioning compared to placebo
2 Assess the effects of repeated weekly dosing of D-cycloserine on cognitive functioning at week 8 compared to placebo
3 Assess the effects of repeated weekly dosing of D-cycloserine on memory functioning once a week 1 hour after medication administration compared to placebo
4 Assess the persistence of learned information in a no-treatment follow-up assessment at Week 10 in the D-cycloserine group compared to the placebo group
5 Assess effects of weekly D-cycloserine dosing on positive negative symptoms at week 8 compared to placebo
6 Assess tolerability and side effects of weekly D-cycloserine compared to placebo
7 Assess the effects of d-cycloserine dosed weekly for seven weeks on reward responsiveness as measured with the response bias task compared with placebo
8 Assess the effects of d-cycloserine dosed weekly for seven weeks on measures of functioning
Specific aims
1 Assess the effects of a single dose of D-cycloserine 50 mg on cognitive functioning compared to placebo
2 Assess the effects of repeated weekly dosing of D-cycloserine on cognitive functioning at week 8 compared to placebo
3 Assess the effects of repeated weekly dosing of D-cycloserine on memory functioning once a week 1 hour after medication administration compared to placebo
4 Assess the persistence of learned information in a no-treatment follow-up assessment at Week 10 in the D-cycloserine group compared to the placebo group
5 Assess effects of weekly D-cycloserine dosing on positive negative symptoms at week 8 compared to placebo
6 Assess tolerability and side effects of weekly D-cycloserine compared to placebo
7 Assess the effects of d-cycloserine dosed weekly for seven weeks on reward responsiveness as measured with the response bias task compared with placebo
8 Assess the effects of d-cycloserine dosed weekly for seven weeks on measures of functioning
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