NCT01678755

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

August 31, 2012

Last Update Submit

July 2, 2021

Conditions

Schizophrenia

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12

    Rater based interview

    Change from baseline to week 12

Secondary Outcomes (3)

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

    Measurements from screening period up through week 12

  • Symptom Severity: PANSS (Positive and Negative Syndrome Scale)

    Measurements from screening period up through week 12

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

    Measurements from screening period up through week 12

Study Arms (3)

ABT-126 Low Dose

EXPERIMENTAL

ABT-126 Low Dose

Drug: ABT-126

ABT-126 High Dose

EXPERIMENTAL

ABT-126 High Dose

Drug: ABT-126

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ABT-126DRUG

ABT-126 Low Dose

ABT-126 Low Dose
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Site Reference ID/Investigator# 74436

Chino, California, 91710, United States

Location

Site Reference ID/Investigator# 72704

Garden Grove, California, 92845, United States

Location

Site Reference ID/Investigator# 72699

National City, California, 91950, United States

Location

Site Reference ID/Investigator# 73983

Oceanside, California, 92056, United States

Location

Site Reference ID/Investigator# 73236

Orange, California, 92868, United States

Location

Site Reference ID/Investigator# 86974

San Diego, California, 92102, United States

Location

Site Reference ID/Investigator# 72701

Torrance, California, 90502, United States

Location

Site Reference ID/Investigator# 75314

Bradenton, Florida, 34201, United States

Location

Site Reference ID/Investigator# 75146

Maitland, Florida, 32751, United States

Location

Site Reference ID/Investigator# 75654

Atlanta, Georgia, 30308, United States

Location

Site Reference ID/Investigator# 72703

Chicago, Illinois, 60640, United States

Location

Site Reference ID/Investigator# 76534

Hoffman Estates, Illinois, 60169, United States

Location

Site Reference ID/Investigator# 73984

Lake Charles, Louisiana, 70629, United States

Location

Site Reference ID/Investigator# 73981

St Louis, Missouri, 63109, United States

Location

Site Reference ID/Investigator# 89553

Marlton, New Jersey, 08053, United States

Location

Site Reference ID/Investigator# 72700

Cedarhurst, New York, 11516, United States

Location

Site Reference ID/Investigator# 73982

New York, New York, 10065, United States

Location

Site Reference ID/Investigator# 113035

Oklahoma City, Oklahoma, 73116, United States

Location

Site Reference ID/Investigator# 72702

DeSoto, Texas, 75115, United States

Location

Site Reference ID/Investigator# 75147

Houston, Texas, 77008, United States

Location

Related Publications (2)

  • Haig GM, Wang D, Zhao J, Othman AA, Bain EE. Efficacy and Safety of the alpha7-Nicotinic Acetylcholine Receptor Agonist ABT-126 in the Treatment of Cognitive Impairment Associated With Schizophrenia: Results From a Phase 2b Randomized Controlled Study in Smokers. J Clin Psychiatry. 2018 May/Jun;79(3):16m11162. doi: 10.4088/JCP.16m11162.

    PMID: 28922590RESULT

  • 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: 28433500DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

ABT-126

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • George Haig, PharmD

    AbbVie

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 5, 2012

Study Start

August 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 7, 2021

Record last verified: 2021-07

Locations

US(20)