A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia

July 2, 2021 updated by: AbbVie (prior sponsor, Abbott)

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Nonsmokers

This is a safety and efficacy study evaluating a 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 safety and efficacy of ABT-126 in treating cognitive deficits in subjects with a diagnosis of schizophrenia. Eligible subjects will take study drug as an add-on treatment to their ongoing antipsychotic treatment regimen.

Study Type

Interventional

Enrollment (Actual)

432

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

  • Russian Federation
      • Chita, Russian Federation, 672090
        • Site Reference ID/Investigator# 94476
      • Ekaterinburg, Russian Federation, 620030
        • Site Reference ID/Investigator# 79515
      • Kazan, Russian Federation, 420061
        • Site Reference ID/Investigator# 94528
      • Lipetsk, Russian Federation, 399083
        • Site Reference ID/Investigator# 79517
      • Moscow, Russian Federation, 107076
        • Site Reference ID/Investigator# 81934
      • Moscow, Russian Federation, 109559
        • Site Reference ID/Investigator# 81935
      • Moscow, Russian Federation, 115419
        • Site Reference ID/Investigator# 79516
      • Novosibirsk, Russian Federation, 630064
        • Site Reference ID/Investigator# 83116
      • Saint-Petersburg, Russian Federation, 195176
        • Site Reference ID/Investigator# 97136
      • Saratov, Russian Federation, 410028
        • Site Reference ID/Investigator# 81933
      • Saratov, Russian Federation, 410060
        • Site Reference ID/Investigator# 79514
      • St. Petersburg, Russian Federation, 190020
        • Site Reference ID/Investigator# 80673
      • St. Petersburg, Russian Federation, 190121
        • Site Reference ID/Investigator# 85093
      • St. Petersburg, Russian Federation, 191119
        • Site Reference ID/Investigator# 97135
      • St. Petersburg, Russian Federation, 191119
        • Site Reference ID/Investigator# 97137
      • St. Petersburg, Russian Federation, 192019
        • Site Reference ID/Investigator# 83115
      • St. Petersburg, Russian Federation, 197341
        • Site Reference ID/Investigator# 84733
      • Stavropol, Russian Federation, 357034
        • Site Reference ID/Investigator# 79520
      • Yaroslavl, Russian Federation, 150003
        • Site Reference ID/Investigator# 83117
      • Yekaterinburg, Russian Federation, 620028
        • Site Reference ID/Investigator# 97138
  • United Kingdom
      • Brentford, United Kingdom, TW8 8DS
        • Site Reference ID/Investigator# 81938
      • Edinburgh, United Kingdom, EH10 5HF
        • Site Reference ID/Investigator# 81940
      • London, United Kingdom, SE5 8AF
        • Site Reference ID/Investigator# 81939
      • London, United Kingdom, W6 8RP
        • Site Reference ID/Investigator# 92813
      • Newcastle upon Tyne, United Kingdom, NE4 5PL
        • Site Reference ID/Investigator# 81937
      • Oxford, United Kingdom, OX3 7JX
        • Site Reference ID/Investigator# 81943
      • Preston, United Kingdom, PR5 6YA
        • Site Reference ID/Investigator# 82238
  • United States
    • California
      • Anaheim, California, United States, 92804
        • Site Reference ID/Investigator# 75139
      • Bellflower, California, United States, 90706
        • Site Reference ID/Investigator# 74894
      • Chino, California, United States, 91710
        • Site Reference ID/Investigator# 74434
      • Costa Mesa, California, United States, 92626
        • Site Reference ID/Investigator# 76593
      • Escondido, California, United States, 92025
        • Site Reference ID/Investigator# 73213
      • Garden Grove, California, United States, 92845
        • Site Reference ID/Investigator# 72698
      • La Habra, California, United States, 90631
        • Site Reference ID/Investigator# 75057
      • National City, California, United States, 91950
        • Site Reference ID/Investigator# 72693
      • Norwalk, California, United States, 90650
        • Site Reference ID/Investigator# 77655
      • Oakland, California, United States, 94612
        • Site Reference ID/Investigator# 74895
      • Oceanside, California, United States, 92056
        • Site Reference ID/Investigator# 73977
      • Orange, California, United States, 92868
        • Site Reference ID/Investigator# 73214
      • Pico Rivera, California, United States, 90660
        • Site Reference ID/Investigator# 74453
      • Riverside, California, United States, 92506
        • Site Reference ID/Investigator# 74898
      • San Bernardino, California, United States, 92408
        • Site Reference ID/Investigator# 98016
      • San Diego, California, United States, 92102
        • Site Reference ID/Investigator# 86973
      • San Diego, California, United States, 92103
        • Site Reference ID/Investigator# 75140
      • San Gabriel, California, United States, 91776
        • Site Reference ID/Investigator# 73974
      • Santa Ana, California, United States, 92705
        • Site Reference ID/Investigator# 74433
      • Torrance, California, United States, 90502
        • Site Reference ID/Investigator# 72695
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Site Reference ID/Investigator# 75136
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Site Reference ID/Investigator# 75653
      • Marietta, Georgia, United States, 30060
        • Site Reference ID/Investigator# 74893
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Site Reference ID/Investigator# 72697
      • Hoffman Estates, Illinois, United States, 60169
        • Site Reference ID/Investigator# 76533
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Site Reference ID/Investigator# 75056
    • New York
      • Cedarhurst, New York, United States, 11516
        • Site Reference ID/Investigator# 72694
      • Rochester, New York, United States, 14623
        • Site Reference ID/Investigator# 75137
      • Staten Island, New York, United States, 10312
        • Site Reference ID/Investigator# 75053
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Site Reference ID/Investigator# 75413
    • Texas
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 74553
      • DeSoto, Texas, United States, 75115
        • Site Reference ID/Investigator# 72696
      • Houston, Texas, United States, 77008
        • Site Reference ID/Investigator# 75055
      • Houston, Texas, United States, 77098
        • Site Reference ID/Investigator# 74896

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).
  • Is clinically stable while receiving a regimen of one or two allowable antipsychotic medications: lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of Positive and Negative Syndrome Scale (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 contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements.

Exclusion Criteria:

  • In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.
  • Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the Screening Period.
  • Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.
  • Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.
  • Has any risk factors for Torsades de Pointes (TdP)

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: ABT-126 Low Dose
Drug: ABT-126
ABT-126 Low Dose
Drug: ABT-126
ABT-126 High Dose
Drug: ABT-126
ABT-126 Middle Dose
Experimental: ABT-126 Middle Dose
Drug: ABT-126
ABT-126 Low Dose
Drug: ABT-126
ABT-126 High Dose
Drug: ABT-126
ABT-126 Middle Dose
Experimental: ABT-126 High Dose
Drug: ABT-126
ABT-126 Low Dose
Drug: ABT-126
ABT-126 High Dose
Drug: ABT-126
ABT-126 Middle Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition: MCCB (MATRICS Consensus Cognitive Battery)
Time Frame: Change from baseline to week 24
Rater based interview
Change from baseline to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)
Time Frame: Measurements from screening period up through week 24
Rater based interview
Measurements from screening period up through week 24
Symptom Severity: PANSS (Positive and Negative Symptom Scale)
Time Frame: Measurements from screening period up through week 24
Rater based interview
Measurements from screening period up through week 24
Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)
Time Frame: Measurements from screening period up through week 24
Rater based interview
Measurements from screening period up through week 24

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

May 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

May 25, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-855
  • 2012-000418-13 (EudraCT Number)

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.

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