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

Cognitive Deficits in Schizophrenia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095562
• Other study ID #: M10-854
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficits in Schizophrenia
• Cognitive Dysfunction
• Schizophrenia

Intervention

Drug:
• ABT-126
ABT-126 Dose 1, ABT-126 Dose 2
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 27071	Beachwood	Ohio
United States	Site Reference ID/Investigator# 26267	Cerritos	California
United States	Site Reference ID/Investigator# 45320	Costa Mesa	California
United States	Site Reference ID/Investigator# 27069	Dallas	Texas
United States	Site Reference ID/Investigator# 27068	Escondido	California
United States	Site Reference ID/Investigator# 26392	Fresh Meadows	New York
United States	Site Reference ID/Investigator# 52568	Garden Grove	California
United States	Site Reference ID/Investigator# 26266	Granada Hills	California
United States	Site Reference ID/Investigator# 26395	Lake Charles	Louisiana
United States	Site Reference ID/Investigator# 36020	Media	Pennsylvania
United States	Site Reference ID/Investigator# 27073	New York	New York
United States	Site Reference ID/Investigator# 28063	Norristown	Pennsylvania
United States	Site Reference ID/Investigator# 26388	Oceanside	California
United States	Site Reference ID/Investigator# 26262	Rochester	New York
United States	Site Reference ID/Investigator# 26268	Saint Louis	Missouri
United States	Site Reference ID/Investigator# 45315	San Bernardino	California
United States	Site Reference ID/Investigator# 26271	San Diego	California
United States	Site Reference ID/Investigator# 27045	Santa Ana	California
United States	Site Reference ID/Investigator# 45314	Santa Ana	California
United States	Site Reference ID/Investigator# 27070	Sellersville	Pennsylvania
United States	Site Reference ID/Investigator# 27072	Tampa	Florida
United States	Site Reference ID/Investigator# 26264	Torrance	California
United States	Site Reference ID/Investigator# 27043	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hashimoto K. Targeting of a7 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition: MCCB		Measurements from screening period through 12-week treatment period
Secondary	Functioning: UPSA-2		Measurements from screening period through 12-week treatment period
Secondary	Cognition: CANTAB		Measurements from screening period through 12-week treatment period
Secondary	Symptom Severity: PANSS, NSA-16, CGI-S		Measurements from screening period through 12-week treatment period