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SchizophreniaPhase 2NCT01655680

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

A Phase 2 study testing ABT-126 in people with Schizophrenia, run by AbbVie (prior sponsor, Abbott) at 61 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a safety and efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
ABT-126
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
432 participants
Where
61 sitesin 3 countries
Study dates
May 2012to Jul 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

61 sites in 3 countries.

61 sites in 3 countries

United States34 sites

  • Site Reference ID/Investigator# 75139

    Anaheim, California, 92804

  • Site Reference ID/Investigator# 75653

    Atlanta, Georgia, 30308

  • Site Reference ID/Investigator# 74894

    Bellflower, California, 90706

  • Site Reference ID/Investigator# 72694

    Cedarhurst, New York, 11516

  • Site Reference ID/Investigator# 72697

    Chicago, Illinois, 60640

  • Site Reference ID/Investigator# 74434

    Chino, California, 91710

  • Site Reference ID/Investigator# 76593

    Costa Mesa, California, 92626

  • Site Reference ID/Investigator# 74553

    Dallas, Texas, 75231

  • Site Reference ID/Investigator# 72696

    DeSoto, Texas, 75115

  • Site Reference ID/Investigator# 73213

    Escondido, California, 92025

  • Site Reference ID/Investigator# 72698

    Garden Grove, California, 92845

  • Site Reference ID/Investigator# 76533

    Hoffman Estates, Illinois, 60169

  • Site Reference ID/Investigator# 75055

    Houston, Texas, 77008

  • Site Reference ID/Investigator# 74896

    Houston, Texas, 77098

  • Site Reference ID/Investigator# 75057

    La Habra, California, 90631

  • Site Reference ID/Investigator# 74893

    Marietta, Georgia, 30060

  • Site Reference ID/Investigator# 72693

    National City, California, 91950

  • Site Reference ID/Investigator# 75136

    New Haven, Connecticut, 06519

  • Site Reference ID/Investigator# 77655

    Norwalk, California, 90650

  • Site Reference ID/Investigator# 74895

    Oakland, California, 94612

  • Site Reference ID/Investigator# 73977

    Oceanside, California, 92056

  • Site Reference ID/Investigator# 73214

    Orange, California, 92868

  • Site Reference ID/Investigator# 75413

    Philadelphia, Pennsylvania, 19139

  • Site Reference ID/Investigator# 74453

    Pico Rivera, California, 90660

  • Site Reference ID/Investigator# 74898

    Riverside, California, 92506

  • Site Reference ID/Investigator# 75137

    Rochester, New York, 14623

  • Site Reference ID/Investigator# 98016

    San Bernardino, California, 92408

  • Site Reference ID/Investigator# 86973

    San Diego, California, 92102

  • Site Reference ID/Investigator# 75140

    San Diego, California, 92103

  • Site Reference ID/Investigator# 73974

    San Gabriel, California, 91776

  • Site Reference ID/Investigator# 74433

    Santa Ana, California, 92705

  • Site Reference ID/Investigator# 75053

    Staten Island, New York, 10312

  • Site Reference ID/Investigator# 72695

    Torrance, California, 90502

  • Site Reference ID/Investigator# 75056

    Wichita, Kansas, 67214

Other trials in United States

Russia20 sites

  • Site Reference ID/Investigator# 94476

    Chita, 672090

  • Site Reference ID/Investigator# 94528

    Kazan', 420061

  • Site Reference ID/Investigator# 79517

    Lipetsk, 399083

  • Site Reference ID/Investigator# 81934

    Moscow, 107076

  • Site Reference ID/Investigator# 81935

    Moscow, 109559

  • Site Reference ID/Investigator# 79516

    Moscow, 115419

  • Site Reference ID/Investigator# 83116

    Novosibirsk, 630064

  • Site Reference ID/Investigator# 80673

    Saint Petersburg, 190020

  • Site Reference ID/Investigator# 85093

    Saint Petersburg, 190121

  • Site Reference ID/Investigator# 97135

    Saint Petersburg, 191119

  • Site Reference ID/Investigator# 97137

    Saint Petersburg, 191119

  • Site Reference ID/Investigator# 83115

    Saint Petersburg, 192019

  • Site Reference ID/Investigator# 97136

    Saint Petersburg, 195176

  • Site Reference ID/Investigator# 84733

    Saint Petersburg, 197341

  • Site Reference ID/Investigator# 81933

    Saratov, 410028

  • Site Reference ID/Investigator# 79514

    Saratov, 410060

  • Site Reference ID/Investigator# 79520

    Stavropol, 357034

  • Site Reference ID/Investigator# 83117

    Yaroslavl, 150003

  • Site Reference ID/Investigator# 97138

    Yekaterinburg, 620028

  • Site Reference ID/Investigator# 79515

    Yekaterinburg, 620030

Other trials in Russia

United Kingdom7 sites

  • Site Reference ID/Investigator# 81938

    Brentford, TW8 8DS

  • Site Reference ID/Investigator# 81940

    Edinburgh, EH10 5HF

  • Site Reference ID/Investigator# 81939

    London, SE5 8AF

  • Site Reference ID/Investigator# 92813

    London, W6 8RP

  • Site Reference ID/Investigator# 81937

    Newcastle upon Tyne, NE4 5PL

  • Site Reference ID/Investigator# 81943

    Oxford, OX3 7JX

  • Site Reference ID/Investigator# 82238

    Preston, PR5 6YA

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Schizophrenia
Being tested
ABT-126, Placebo
Keywords
Schizophrenia
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-126Drug

    ABT-126 Middle Dose

  • ABT-126Drug

    ABT-126 Low Dose

  • ABT-126Drug

    ABT-126 High Dose

  • PlaceboDrug

    Placebo

Study groups in NCT01655680
Study groupRoleWhat they receive
ABT-126 Low DoseExperimentalABT-126 Low Dose
Receives: Drug: ABT-126
ABT-126 Middle DoseExperimentalABT-126 Middle Dose
Receives: Drug: ABT-126
ABT-126 High DoseExperimentalABT-126 High Dose
Receives: Drug: ABT-126
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognition: MCCB (MATRICS Consensus Cognitive Battery)

    Rater based interview

    Measured: Change from baseline to week 24

Secondary outcomes (3)

  1. Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)

    Rater based interview

    Measured: Measurements from screening period up through week 24

  2. Symptom Severity: PANSS (Positive and Negative Symptom Scale)

    Rater based interview

    Measured: Measurements from screening period up through week 24

  3. Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)

    Rater based interview

    Measured: Measurements from screening period up through week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionApr 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
432 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01655680
Sponsor's protocol ID
M10-855
Other IDs
2012-000418-13
Status last verified
Jul 2021
First submitted
25 May 2012
Last updated
7 Jul 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Haig G, Wang D, Othman AA, Zhao J. The alpha7 Nicotinic Agonist ABT-126 in the Treatment of Cognitive Impairment Associated with Schizophrenia in Nonsmokers: Results from a Randomized Controlled Phase 2b Study. Neuropsychopharmacology. 2016 Nov;41(12):2893-2902. doi: 10.1038/npp.2016.101. Epub 2016 Jun 20.

    PubMed 27319970

  • 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.

    PubMed 28433500

  • Bain EE, Shafner L, Walling DP, Othman AA, Chuang-Stein C, Hinkle J, Hanina A. Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia. JMIR Mhealth Uhealth. 2017 Feb 21;5(2):e18. doi: 10.2196/mhealth.7030.

    PubMed 28223265

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-126 in people with Schizophrenia, run by AbbVie (prior sponsor, Abbott) at 61 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Russia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognition: MCCB (MATRICS Consensus Cognitive Battery) (time frame: Change from baseline to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01655680, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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