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

June 1, 2018 updated by: AbbVie (prior sponsor, Abbott)

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cerritos, California, United States, 90703
        • Site Reference ID/Investigator# 26267
      • Costa Mesa, California, United States, 92626
        • Site Reference ID/Investigator# 45320
      • Escondido, California, United States, 92025
        • Site Reference ID/Investigator# 27068
      • Garden Grove, California, United States, 92845
        • Site Reference ID/Investigator# 52568
      • Granada Hills, California, United States, 91344
        • Site Reference ID/Investigator# 26266
      • Oceanside, California, United States, 92056
        • Site Reference ID/Investigator# 26388
      • San Bernardino, California, United States, 92408
        • Site Reference ID/Investigator# 45315
      • San Diego, California, United States, 92102
        • Site Reference ID/Investigator# 26271
      • Santa Ana, California, United States, 92701
        • Site Reference ID/Investigator# 27045
      • Santa Ana, California, United States, 92705
        • Site Reference ID/Investigator# 45314
      • Torrance, California, United States, 90502
        • Site Reference ID/Investigator# 26264
    • Florida
      • Tampa, Florida, United States, 33613
        • Site Reference ID/Investigator# 27072
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Site Reference ID/Investigator# 27043
    • Louisiana
      • Lake Charles, Louisiana, United States, 70629
        • Site Reference ID/Investigator# 26395
    • Missouri
      • Saint Louis, Missouri, United States, 63118
        • Site Reference ID/Investigator# 26268
    • New York
      • Fresh Meadows, New York, United States, 11366
        • Site Reference ID/Investigator# 26392
      • New York, New York, United States, 10065
        • Site Reference ID/Investigator# 27073
      • Rochester, New York, United States, 14618
        • Site Reference ID/Investigator# 26262
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Site Reference ID/Investigator# 27071
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Site Reference ID/Investigator# 36020
      • Norristown, Pennsylvania, United States, 19401
        • Site Reference ID/Investigator# 28063
      • Sellersville, Pennsylvania, United States, 18960
        • Site Reference ID/Investigator# 27070
    • Texas
      • Dallas, Texas, United States, 75243
        • Site Reference ID/Investigator# 27069

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Sugar Pill
Drug: Placebo
Placebo
EXPERIMENTAL: ABT-126 Dose 1
Drug: ABT-126
ABT-126 Dose 1, ABT-126 Dose 2
EXPERIMENTAL: ABT-126 Dose 2
Drug: ABT-126
ABT-126 Dose 1, ABT-126 Dose 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognition: MCCB
Time Frame: Measurements from screening period through 12-week treatment period
Measurements from screening period through 12-week treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Functioning: UPSA-2
Time Frame: Measurements from screening period through 12-week treatment period
Measurements from screening period through 12-week treatment period
Cognition: CANTAB
Time Frame: Measurements from screening period through 12-week treatment period
Measurements from screening period through 12-week treatment period
Symptom Severity: PANSS, NSA-16, CGI-S
Time Frame: Measurements from screening period through 12-week treatment period
Measurements from screening period through 12-week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

March 26, 2010

First Submitted That Met QC Criteria

March 26, 2010

First Posted (ESTIMATE)

March 30, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-854

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Deficits in Schizophrenia

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe