A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia

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) in Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678755
• Other study ID #: M13-608
• Status: Completed
• Phase: Phase 2
• Start date: August 2012
• Est. completion date: March 2014

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Schizophrenia

Intervention

Drug:
• ABT-126
ABT-126 Low Dose
• ABT-126
ABT-126 High Dose
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 75654	Atlanta	Georgia
United States	Site Reference ID/Investigator# 75314	Bradenton	Florida
United States	Site Reference ID/Investigator# 72700	Cedarhurst	New York
United States	Site Reference ID/Investigator# 72703	Chicago	Illinois
United States	Site Reference ID/Investigator# 74436	Chino	California
United States	Site Reference ID/Investigator# 72702	DeSoto	Texas
United States	Site Reference ID/Investigator# 72704	Garden Grove	California
United States	Site Reference ID/Investigator# 76534	Hoffman Estates	Illinois
United States	Site Reference ID/Investigator# 75147	Houston	Texas
United States	Site Reference ID/Investigator# 73984	Lake Charles	Louisiana
United States	Site Reference ID/Investigator# 75146	Maitland	Florida
United States	Site Reference ID/Investigator# 89553	Marlton	New Jersey
United States	Site Reference ID/Investigator# 72699	National City	California
United States	Site Reference ID/Investigator# 73982	New York	New York
United States	Site Reference ID/Investigator# 73983	Oceanside	California
United States	Site Reference ID/Investigator# 113035	Oklahoma City	Oklahoma
United States	Site Reference ID/Investigator# 73236	Orange	California
United States	Site Reference ID/Investigator# 73981	Saint Louis	Missouri
United States	Site Reference ID/Investigator# 86974	San Diego	California
United States	Site Reference ID/Investigator# 72701	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Haig GM, Wang D, Zhao J, Othman AA, Bain EE. Efficacy and Safety of the a7-Nicotinic Acetylcholine Receptor Agonist ABT-126 in the Treatment of Cognitive Impairment Associated With Schizophrenia: Results From a Phase 2b Randomized Controlled Study in Smok — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12	Rater based interview	Change from baseline to week 12
Secondary	Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)	Rater based interview	Measurements from screening period up through week 12
Secondary	Symptom Severity: PANSS (Positive and Negative Syndrome Scale)	Rater based interview	Measurements from screening period up through week 12
Secondary	Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)	Rater based interview	Measurements from screening period up through week 12