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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: ABT-126

• Registration Number: NCT01678755
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-05
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Disposition First Submitted: 2015-03-04
• Disposition First Submitted QC: 2015-03-04
• Disposition First Posted: 2015-03-24
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
ABT-126 Low Dose	ABT-126	ABT-126 Low Dose
ABT-126 High Dose	ABT-126	ABT-126 High Dose

Primary Outcome Measures

Name	Time	Method
Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12	Change from baseline to week 12	Rater based interview

Secondary Outcome Measures

Name	Time	Method
Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)	Measurements from screening period up through week 12	Rater based interview
Symptom Severity: PANSS (Positive and Negative Syndrome Scale)	Measurements from screening period up through week 12	Rater based interview
Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)	Measurements from screening period up through week 12	Rater based interview

Trial Locations

Locations (20)

Site Reference ID/Investigator# 73984; 🇺🇸 Lake Charles, Louisiana, 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# 73981; 🇺🇸 Saint Louis, Missouri, United States

Site Reference ID/Investigator# 74436; 🇺🇸 Chino, California, United States

Site Reference ID/Investigator# 72699; 🇺🇸 National City, California, United States

Site Reference ID/Investigator# 73236; 🇺🇸 Orange, California, United States

Site Reference ID/Investigator# 89553; 🇺🇸 Marlton, New Jersey, United States

Site Reference ID/Investigator# 75146; 🇺🇸 Maitland, Florida, United States

Site Reference ID/Investigator# 76534; 🇺🇸 Hoffman Estates, Illinois, United States

Site Reference ID/Investigator# 72701; 🇺🇸 Torrance, California, United States

Site Reference ID/Investigator# 75314; 🇺🇸 Bradenton, Florida, United States

Site Reference ID/Investigator# 75654; 🇺🇸 Atlanta, Georgia, United States

Site Reference ID/Investigator# 72703; 🇺🇸 Chicago, Illinois, United States

Site Reference ID/Investigator# 86974; 🇺🇸 San Diego, California, United States

Site Reference ID/Investigator# 75147; 🇺🇸 Houston, Texas, United States

Site Reference ID/Investigator# 113035; 🇺🇸 Oklahoma City, Oklahoma, United States

Site Reference ID/Investigator# 73983; 🇺🇸 Oceanside, California, United States

Site Reference ID/Investigator# 72700; 🇺🇸 Cedarhurst, New York, United States

Site Reference ID/Investigator# 73982; 🇺🇸 New York, New York, United States