Cognitive Deficits in Schizophrenia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-288 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
NCT number | NCT01077700 |
Other study ID # | M10-503 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2010 |
Est. completion date | July 2011 |
Verified date | January 2013 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
Status | Completed |
Enrollment | 214 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Has current DSM-IV-TR diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview. - Is clinically stable while receiving antipsychotic therapy with one or two atypical antipsychotic medications: lack of hospitalizations from 4 months of Initial Screening Visit; taking same antipsychotic medication(s) for at least 8 weeks prior to the Day -1 visit; core positive symptoms of PANSS no worse than moderate in severity throughout Screening Period of at least 4 weeks. - Has been diagnosed with or treated for schizophrenia for at least 2 years prior to Initial Screening Visit. - Has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to Initial Screening Visit. - Has an identified responsible contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject and ensure compliance with protocol requirements. Exclusion Criteria: - Has valid current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, posttraumatic stress disorder, obsessive compulsive disorder, or a current major depressive episode. - Has history of substance abuse (excluding nicotine or tobacco products) or alcohol abuse within 6 months prior to Screening Visit; has a substance dependence disorder (excluding nicotine or tobacco products) that has not been remitted for at least 1 year prior to Initial Screening Visit. - Is taking any medication for extrapyramidal symptoms at any time from the Initial Screening Visit until the Day -1 Visit. - Is taking any antidepressant that is excluded, including tricyclic antidepressants and monoamine oxidase inhibitors, at any time from 8 weeks prior to the Day -1 Visit. - Has significant suicidal ideation at Initial Screening Visit. - Has had a suicide attempt within 1 year prior to the Day -1 Visit. - Has participated in another trial utilizing the MATRICS Consensus Cognitive Battery (MCCB) or UCSD Performance-Based Skills Assessment (UPSA) (any version) within 6 months prior to Initial Screening Visit. - Is currently enrolled in any form of cognitive remediation training. |
Country | Name | City | State |
---|---|---|---|
United States | Site Reference ID/Investigator# 21662 | Anaheim | California |
United States | Site Reference ID/Investigator# 21582 | Austin | Texas |
United States | Site Reference ID/Investigator# 21590 | Austin | Texas |
United States | Site Reference ID/Investigator# 27502 | Bellevue | Washington |
United States | Site Reference ID/Investigator# 26409 | Brooklyn | New York |
United States | Site Reference ID/Investigator# 21588 | Cedarhurst | New York |
United States | Site Reference ID/Investigator# 26399 | Charleston | South Carolina |
United States | Site Reference ID/Investigator# 21681 | Chicago | Illinois |
United States | Site Reference ID/Investigator# 21589 | Dayton | Ohio |
United States | Site Reference ID/Investigator# 26406 | DeSoto | Texas |
United States | Site Reference ID/Investigator# 21683 | Garden Grove | California |
United States | Site Reference ID/Investigator# 26402 | Houston | Texas |
United States | Site Reference ID/Investigator# 21581 | National City | California |
United States | Site Reference ID/Investigator# 45310 | Norwalk | California |
United States | Site Reference ID/Investigator# 26407 | Oklahoma City | Oklahoma |
United States | Site Reference ID/Investigator# 26400 | Pasadena | California |
United States | Site Reference ID/Investigator# 21601 | Philadelphia | Pennsylvania |
United States | Site Reference ID/Investigator# 21584 | Pico Rivera | California |
United States | Site Reference ID/Investigator# 21761 | Pittsfield | Massachusetts |
United States | Site Reference ID/Investigator# 46603 | Plantation | Florida |
United States | Site Reference ID/Investigator# 45312 | Riverside | California |
United States | Site Reference ID/Investigator# 21591 | Saint Louis | Missouri |
United States | Site Reference ID/Investigator# 45309 | San Diego | California |
United States | Site Reference ID/Investigator# 26397 | Shreveport | Louisiana |
Lead Sponsor | Collaborator |
---|---|
AbbVie (prior sponsor, Abbott) |
United States,
Haig GM, Bain E, Robieson W, Othman AA, Baker J, Lenz RA. A randomized trial of the efficacy and safety of the H3 antagonist ABT-288 in cognitive impairment associated with schizophrenia. Schizophr Bull. 2014 Nov;40(6):1433-42. doi: 10.1093/schbul/sbt240. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognition: MCCB | Measurements from screening period through 12-week treatment period | ||
Secondary | Functioning: UPSA-2 | Measurements from screening period through 12-week treatment period | ||
Secondary | Cognition: CANTAB | Measurements from screening period through 12-week treatment period | ||
Secondary | Symptom Severity: PANSS, NSA-16, CGI-S | Measurements from screening period through 12-week treatment period |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01095562 -
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects With Schizophrenia
|
Phase 2 |