Clinical trial NCT01678755: A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-09-05
Enrollment: 157
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12
timeFrame: Change from baseline to week 12
Secondary outcomes:
measure: Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)
timeFrame: Measurements from screening period up through week 12
measure: Symptom Severity: PANSS (Positive and Negative Syndrome Scale)
timeFrame: Measurements from screening period up through week 12
measure: Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)
timeFrame: Measurements from screening period up through week 12
Other outcomes:
Locations:
city: Chino
country: United States
facility: Site Reference ID/Investigator# 74436
state: California
city: Garden Grove
country: United States
facility: Site Reference ID/Investigator# 72704
state: California
city: National City
country: United States
facility: Site Reference ID/Investigator# 72699
state: California
city: Oceanside
country: United States
facility: Site Reference ID/Investigator# 73983
state: California
city: Orange
country: United States
facility: Site Reference ID/Investigator# 73236
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 86974
state: California
city: Torrance
country: United States
facility: Site Reference ID/Investigator# 72701
state: California
city: Bradenton
country: United States
facility: Site Reference ID/Investigator# 75314
state: Florida
city: Maitland
country: United States
facility: Site Reference ID/Investigator# 75146
state: Florida
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 75654
state: Georgia
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 72703
state: Illinois
city: Hoffman Estates
country: United States
facility: Site Reference ID/Investigator# 76534
state: Illinois
city: Lake Charles
country: United States
facility: Site Reference ID/Investigator# 73984
state: Louisiana
city: Saint Louis
country: United States
facility: Site Reference ID/Investigator# 73981
state: Missouri
city: Marlton
country: United States
facility: Site Reference ID/Investigator# 89553
state: New Jersey
city: Cedarhurst
country: United States
facility: Site Reference ID/Investigator# 72700
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 73982
state: New York
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 113035
state: Oklahoma
city: DeSoto
country: United States
facility: Site Reference ID/Investigator# 72702
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 75147
state: Texas
Study officials:
affiliation: AbbVie
name: George Haig, PharmD
role: STUDY_DIRECTOR
References:
citation: Haig GM, Wang D, Zhao J, Othman AA, Bain EE. Efficacy and Safety of the alpha7-Nicotinic Acetylcholine Receptor Agonist ABT-126 in the Treatment of Cognitive Impairment Associated With Schizophrenia: Results From a Phase 2b Randomized Controlled Study in Smokers. J Clin Psychiatry. 2018 May/Jun;79(3):16m11162. doi: 10.4088/JCP.16m11162.
citation: 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.