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

NCT01077700 | Completed Phase 2 DMC

• 1 other identifier: M10-503
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Cognitive Deficits in Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Cognition: MCCB

  Measurements from screening period through 12-week treatment period

Secondary Outcomes (3)

• Functioning: UPSA-2

  Measurements from screening period through 12-week treatment period

• Cognition: CANTAB

  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

Study Arms (3)

ABT-288 Dose 1

EXPERIMENTAL

low dose of ABT-288

Drug: ABT-288 Low Dose

ABT-288 Dose 2

EXPERIMENTAL

high dose of ABT-288

Drug: ABT-288 High Dose

Sugar Pill

PLACEBO COMPARATOR

inactive substance

Drug: Placebo

Interventions

ABT-288 Low Dose DRUG

ABT-288 Dose 1

Placebo DRUG

inactive substance

Sugar Pill

ABT-288 High Dose DRUG

ABT-288 Dose 2

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (24)

Site Reference ID/Investigator# 21662

Anaheim, California, 92804, United States

Location

Site Reference ID/Investigator# 21683

Garden Grove, California, 92845, United States

Location

Site Reference ID/Investigator# 21581

National City, California, 91950, United States

Location

Site Reference ID/Investigator# 45310

Norwalk, California, 90650, United States

Location

Site Reference ID/Investigator# 26400

Pasadena, California, 91106, United States

Location

Site Reference ID/Investigator# 21584

Pico Rivera, California, 90660, United States

Location

Site Reference ID/Investigator# 45312

Riverside, California, 92506, United States

Location

Site Reference ID/Investigator# 45309

San Diego, California, 92128, United States

Location

Site Reference ID/Investigator# 46603

Plantation, Florida, 33317, United States

Location

Site Reference ID/Investigator# 21681

Chicago, Illinois, 60640, United States

Location

Site Reference ID/Investigator# 26397

Shreveport, Louisiana, 71104-2136, United States

Location

Site Reference ID/Investigator# 21761

Pittsfield, Massachusetts, 01201, United States

Location

Site Reference ID/Investigator# 21591

St Louis, Missouri, 63139, United States

Location

Site Reference ID/Investigator# 26409

Brooklyn, New York, 11235, United States

Location

Site Reference ID/Investigator# 21588

Cedarhurst, New York, 11516, United States

Location

Site Reference ID/Investigator# 21589

Dayton, Ohio, 45417, United States

Location

Site Reference ID/Investigator# 26407

Oklahoma City, Oklahoma, 73103, United States

Location

Site Reference ID/Investigator# 21601

Philadelphia, Pennsylvania, 19131, United States

Location

Site Reference ID/Investigator# 26399

Charleston, South Carolina, 29407, United States

Location

Site Reference ID/Investigator# 21590

Austin, Texas, 78731, United States

Location

Site Reference ID/Investigator# 21582

Austin, Texas, 78754, United States

Location

Site Reference ID/Investigator# 26406

DeSoto, Texas, 75115, United States

Location

Site Reference ID/Investigator# 26402

Houston, Texas, 77008, United States

Location

Site Reference ID/Investigator# 27502

Bellevue, Washington, 98007, United States

Location

Related Publications (2)

• 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.

  PMID: 24516190 RESULT

• 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.

  PMID: 28433500 DERIVED

MeSH Terms

Interventions

2-(4'-(5-methylhexahydropyrrolo(3,4-b)pyrrol-1-yl)biphenyl-4-yl)-2H-pyridazin-3-one

Study Officials

• George Haig, PharmD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 1, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 6, 2018

Record last verified: 2013-01

Locations

US (24)