Clinical trial NCT01095562: Safety and Efficacy 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-126 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: 2010-03-30
Enrollment: 207
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-126 in approximately 210 adults with schizophrenia. Subjects will be randomized to one of three treatment groups (ABT-126 Dose 1, ABT-126 Dose 2 or placebo) for a 12-week Treatment Period. The purpose of this research study is to find out whether ABT-126 compared to placebo can improve cognition and what side effects ABT-126 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: Cerritos
country: United States
facility: Site Reference ID/Investigator# 26267
state: California
city: Costa Mesa
country: United States
facility: Site Reference ID/Investigator# 45320
state: California
city: Escondido
country: United States
facility: Site Reference ID/Investigator# 27068
state: California
city: Garden Grove
country: United States
facility: Site Reference ID/Investigator# 52568
state: California
city: Granada Hills
country: United States
facility: Site Reference ID/Investigator# 26266
state: California
city: Oceanside
country: United States
facility: Site Reference ID/Investigator# 26388
state: California
city: San Bernardino
country: United States
facility: Site Reference ID/Investigator# 45315
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 26271
state: California
city: Santa Ana
country: United States
facility: Site Reference ID/Investigator# 27045
state: California
city: Santa Ana
country: United States
facility: Site Reference ID/Investigator# 45314
state: California
city: Torrance
country: United States
facility: Site Reference ID/Investigator# 26264
state: California
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 27072
state: Florida
city: Wichita
country: United States
facility: Site Reference ID/Investigator# 27043
state: Kansas
city: Lake Charles
country: United States
facility: Site Reference ID/Investigator# 26395
state: Louisiana
city: Saint Louis
country: United States
facility: Site Reference ID/Investigator# 26268
state: Missouri
city: Fresh Meadows
country: United States
facility: Site Reference ID/Investigator# 26392
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 27073
state: New York
city: Rochester
country: United States
facility: Site Reference ID/Investigator# 26262
state: New York
city: Beachwood
country: United States
facility: Site Reference ID/Investigator# 27071
state: Ohio
city: Media
country: United States
facility: Site Reference ID/Investigator# 36020
state: Pennsylvania
city: Norristown
country: United States
facility: Site Reference ID/Investigator# 28063
state: Pennsylvania
city: Sellersville
country: United States
facility: Site Reference ID/Investigator# 27070
state: Pennsylvania
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 27069
state: Texas
Study officials:
affiliation: AbbVie
name: George Haig, PharmD
role: STUDY_DIRECTOR
References:
citation: Hashimoto K. Targeting of alpha7 Nicotinic Acetylcholine Receptors in the Treatment of Schizophrenia and the Use of Auditory Sensory Gating as a Translational Biomarker. Curr Pharm Des. 2015;21(26):3797-806. doi: 10.2174/1381612821666150605111345.
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.