Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Cognitive Deficits in Schizophrenia

In brief

This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.

Key facts

Study ID

NCT01077700

Run by

AbbVie (prior sponsor, Abbott)

People needed

214

Starts

2010-03-01

Expected to finish

2011-07-01

Last updated by the study team

2018-06-06

Who can join

Age: 20 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 21662 — Anaheim, California, United States
• Site Reference ID/Investigator# 21683 — Garden Grove, California, 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# 26400 — Pasadena, California, United States
• Site Reference ID/Investigator# 21584 — Pico Rivera, California, United States
• Site Reference ID/Investigator# 45312 — Riverside, California, United States
• Site Reference ID/Investigator# 45309 — San Diego, California, United States
• Site Reference ID/Investigator# 46603 — Plantation, Florida, United States
• Site Reference ID/Investigator# 21681 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 26397 — Shreveport, Louisiana, United States
• Site Reference ID/Investigator# 21761 — Pittsfield, Massachusetts, United States
• Site Reference ID/Investigator# 21591 — St Louis, Missouri, 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# 21589 — Dayton, Ohio, United States
• Site Reference ID/Investigator# 26407 — Oklahoma City, Oklahoma, United States
• Site Reference ID/Investigator# 21601 — Philadelphia, Pennsylvania, United States
• Site Reference ID/Investigator# 26399 — Charleston, South Carolina, United States
• Site Reference ID/Investigator# 21590 — Austin, Texas, United States
• Site Reference ID/Investigator# 21582 — Austin, Texas, United States
• Site Reference ID/Investigator# 26406 — DeSoto, Texas, United States
• Site Reference ID/Investigator# 26402 — Houston, Texas, United States
• Site Reference ID/Investigator# 27502 — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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