Clinical trial NCT01077700: Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With Schizophrenia
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cognitive Deficits in Schizophrenia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-03-01
Enrollment: 214
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Cognition: MCCB
timeFrame: Measurements from screening period through 12-week treatment period
Secondary outcomes:
measure: Functioning: UPSA-2
timeFrame: Measurements from screening period through 12-week treatment period
measure: Cognition: CANTAB
timeFrame: Measurements from screening period through 12-week treatment period
measure: Symptom Severity: PANSS, NSA-16, CGI-S
timeFrame: Measurements from screening period through 12-week treatment period
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 21662
state: California
city: Garden Grove
country: United States
facility: Site Reference ID/Investigator# 21683
state: California
city: National City
country: United States
facility: Site Reference ID/Investigator# 21581
state: California
city: Norwalk
country: United States
facility: Site Reference ID/Investigator# 45310
state: California
city: Pasadena
country: United States
facility: Site Reference ID/Investigator# 26400
state: California
city: Pico Rivera
country: United States
facility: Site Reference ID/Investigator# 21584
state: California
city: Riverside
country: United States
facility: Site Reference ID/Investigator# 45312
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 45309
state: California
city: Plantation
country: United States
facility: Site Reference ID/Investigator# 46603
state: Florida
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 21681
state: Illinois
city: Shreveport
country: United States
facility: Site Reference ID/Investigator# 26397
state: Louisiana
city: Pittsfield
country: United States
facility: Site Reference ID/Investigator# 21761
state: Massachusetts
city: Saint Louis
country: United States
facility: Site Reference ID/Investigator# 21591
state: Missouri
city: Brooklyn
country: United States
facility: Site Reference ID/Investigator# 26409
state: New York
city: Cedarhurst
country: United States
facility: Site Reference ID/Investigator# 21588
state: New York
city: Dayton
country: United States
facility: Site Reference ID/Investigator# 21589
state: Ohio
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 26407
state: Oklahoma
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 21601
state: Pennsylvania
city: Charleston
country: United States
facility: Site Reference ID/Investigator# 26399
state: South Carolina
city: Austin
country: United States
facility: Site Reference ID/Investigator# 21590
state: Texas
city: Austin
country: United States
facility: Site Reference ID/Investigator# 21582
state: Texas
city: DeSoto
country: United States
facility: Site Reference ID/Investigator# 26406
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 26402
state: Texas
city: Bellevue
country: United States
facility: Site Reference ID/Investigator# 27502
state: Washington
Study officials:
affiliation: AbbVie
name: George Haig, PharmD
role: STUDY_DIRECTOR
References:
citation: 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. Epub 2014 Feb 10.
citation: Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.