NCT01095562

Brief Summary

This is an efficacy and safety study evaluating an 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
207

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

23 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

March 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 6, 2018

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

March 26, 2010

Last Update Submit

June 1, 2018

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-126 Dose 1

EXPERIMENTAL
Drug: ABT-126

ABT-126 Dose 2

EXPERIMENTAL
Drug: ABT-126

Sugar Pill

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ABT-126DRUG

ABT-126 Dose 1, ABT-126 Dose 2

ABT-126 Dose 1ABT-126 Dose 2
PlaceboDRUG

Placebo

Sugar Pill

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Site Reference ID/Investigator# 26267

Cerritos, California, 90703, United States

Location

Site Reference ID/Investigator# 45320

Costa Mesa, California, 92626, United States

Location

Site Reference ID/Investigator# 27068

Escondido, California, 92025, United States

Location

Site Reference ID/Investigator# 52568

Garden Grove, California, 92845, United States

Location

Site Reference ID/Investigator# 26266

Granada Hills, California, 91344, United States

Location

Site Reference ID/Investigator# 26388

Oceanside, California, 92056, United States

Location

Site Reference ID/Investigator# 45315

San Bernardino, California, 92408, United States

Location

Site Reference ID/Investigator# 26271

San Diego, California, 92102, United States

Location

Site Reference ID/Investigator# 27045

Santa Ana, California, 92701, United States

Location

Site Reference ID/Investigator# 45314

Santa Ana, California, 92705, United States

Location

Site Reference ID/Investigator# 26264

Torrance, California, 90502, United States

Location

Site Reference ID/Investigator# 27072

Tampa, Florida, 33613, United States

Location

Site Reference ID/Investigator# 27043

Wichita, Kansas, 67214, United States

Location

Site Reference ID/Investigator# 26395

Lake Charles, Louisiana, 70629, United States

Location

Site Reference ID/Investigator# 26268

St Louis, Missouri, 63118, United States

Location

Site Reference ID/Investigator# 26392

Fresh Meadows, New York, 11366, United States

Location

Site Reference ID/Investigator# 27073

New York, New York, 10065, United States

Location

Site Reference ID/Investigator# 26262

Rochester, New York, 14618, United States

Location

Site Reference ID/Investigator# 27071

Beachwood, Ohio, 44122, United States

Location

Site Reference ID/Investigator# 36020

Media, Pennsylvania, 19063, United States

Location

Site Reference ID/Investigator# 28063

Norristown, Pennsylvania, 19401, United States

Location

Site Reference ID/Investigator# 27070

Sellersville, Pennsylvania, 18960, United States

Location

Site Reference ID/Investigator# 27069

Dallas, Texas, 75243, United States

Location

Related Publications (2)

  • Hashimoto K. Targeting of alpha7 Nicotinic Acetylcholine Receptors in the Treatment of Schizophrenia and the Use of Auditory Sensory Gating as a Translational Biomarker. Curr Pharm Des. 2015;21(26):3797-806. doi: 10.2174/1381612821666150605111345.

    PMID: 26044974BACKGROUND

  • 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

Interventions

ABT-126

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

March 26, 2010

First Posted

March 30, 2010

Study Start

March 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

June 6, 2018

Record last verified: 2013-01

Locations

US(23)