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
NCT number | NCT01678755 |
Other study ID # | M13-608 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 2012 |
Est. completion date | March 2014 |
Verified date | July 2021 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
AbbVie (prior sponsor, Abbott) |
United States,
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
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 |
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