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)
Overview
- Phase
- Phase 2
- Intervention
- ABT-288 Low Dose
- Conditions
- Cognitive Deficits in Schizophrenia
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 214
- Locations
- 24
- Primary Endpoint
- Cognition: MCCB
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
Detailed Description
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-288 in approximately 210 adults with schizophrenia. Subjects will be randomized to one of three treatment groups (ABT-288 Dose 1, ABT-288 Dose 2 or placebo) for a 12-week Treatment Period. The purpose of this research study is to find out whether ABT-288 compared to placebo can improve cognition and what side effects ABT 288 may cause. Cognition is the way a person thinks, and it includes abilities like paying attention, focusing, remembering things, and solving problems. Acronyms listed in the Outcomes and/or Eligibility sections for this study are defined below: * MCCB: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery * UPSA-2: University of California at San Diego (UCSD) Performance-Based Skills Assessment-2 * CANTAB: Cambridge Neuropsychological Test Automated Battery * PANSS: Positive and Negative Syndrome Scale * NSA-16: Negative Symptom Assessment-16 * CGI-S: Clinical Global Impression - Severity
Investigators
Eligibility Criteria
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.
Arms & Interventions
ABT-288 Dose 1
low dose of ABT-288
Intervention: ABT-288 Low Dose
ABT-288 Dose 2
high dose of ABT-288
Intervention: ABT-288 High Dose
Sugar Pill
inactive substance
Intervention: Placebo
Outcomes
Primary Outcomes
Cognition: MCCB
Time Frame: Measurements from screening period through 12-week treatment period
Secondary Outcomes
- Functioning: UPSA-2(Measurements from screening period through 12-week treatment period)
- Symptom Severity: PANSS, NSA-16, CGI-S(Measurements from screening period through 12-week treatment period)
- Cognition: CANTAB(Measurements from screening period through 12-week treatment period)