Clinical trial NCT01655680: A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Nonsmokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-08-02
Enrollment: 432
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.

Detailed description: This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-126 in treating cognitive deficits in subjects with a diagnosis of schizophrenia. Eligible subjects will take study drug as an add-on treatment to their ongoing antipsychotic treatment regimen.

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)
timeFrame: Change from baseline to week 24
Secondary outcomes:
measure: Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)
timeFrame: Measurements from screening period up through week 24
measure: Symptom Severity: PANSS (Positive and Negative Symptom Scale)
timeFrame: Measurements from screening period up through week 24
measure: Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)
timeFrame: Measurements from screening period up through week 24
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 75139
state: California
city: Bellflower
country: United States
facility: Site Reference ID/Investigator# 74894
state: California
city: Chino
country: United States
facility: Site Reference ID/Investigator# 74434
state: California
city: Costa Mesa
country: United States
facility: Site Reference ID/Investigator# 76593
state: California
city: Escondido
country: United States
facility: Site Reference ID/Investigator# 73213
state: California
city: Garden Grove
country: United States
facility: Site Reference ID/Investigator# 72698
state: California
city: La Habra
country: United States
facility: Site Reference ID/Investigator# 75057
state: California
city: National City
country: United States
facility: Site Reference ID/Investigator# 72693
state: California
city: Norwalk
country: United States
facility: Site Reference ID/Investigator# 77655
state: California
city: Oakland
country: United States
facility: Site Reference ID/Investigator# 74895
state: California
city: Oceanside
country: United States
facility: Site Reference ID/Investigator# 73977
state: California
city: Orange
country: United States
facility: Site Reference ID/Investigator# 73214
state: California
city: Pico Rivera
country: United States
facility: Site Reference ID/Investigator# 74453
state: California
city: Riverside
country: United States
facility: Site Reference ID/Investigator# 74898
state: California
city: San Bernardino
country: United States
facility: Site Reference ID/Investigator# 98016
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 86973
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 75140
state: California
city: San Gabriel
country: United States
facility: Site Reference ID/Investigator# 73974
state: California
city: Santa Ana
country: United States
facility: Site Reference ID/Investigator# 74433
state: California
city: Torrance
country: United States
facility: Site Reference ID/Investigator# 72695
state: California
city: New Haven
country: United States
facility: Site Reference ID/Investigator# 75136
state: Connecticut
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 75653
state: Georgia
city: Marietta
country: United States
facility: Site Reference ID/Investigator# 74893
state: Georgia
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 72697
state: Illinois
city: Hoffman Estates
country: United States
facility: Site Reference ID/Investigator# 76533
state: Illinois
city: Wichita
country: United States
facility: Site Reference ID/Investigator# 75056
state: Kansas
city: Cedarhurst
country: United States
facility: Site Reference ID/Investigator# 72694
state: New York
city: Rochester
country: United States
facility: Site Reference ID/Investigator# 75137
state: New York
city: Staten Island
country: United States
facility: Site Reference ID/Investigator# 75053
state: New York
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 75413
state: Pennsylvania
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 74553
state: Texas
city: DeSoto
country: United States
facility: Site Reference ID/Investigator# 72696
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 75055
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 74896
state: Texas
city: Chita
country: Russian Federation
facility: Site Reference ID/Investigator# 94476
city: Ekaterinburg
country: Russian Federation
facility: Site Reference ID/Investigator# 79515
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 94528
city: Lipetsk
country: Russian Federation
facility: Site Reference ID/Investigator# 79517
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 81934
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 81935
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 79516
city: Novosibirsk
country: Russian Federation
facility: Site Reference ID/Investigator# 83116
city: Saint-Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 97136
city: Saratov
country: Russian Federation
facility: Site Reference ID/Investigator# 81933
city: Saratov
country: Russian Federation
facility: Site Reference ID/Investigator# 79514
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 80673
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 85093
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 97135
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 97137
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 83115
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 84733
city: Stavropol
country: Russian Federation
facility: Site Reference ID/Investigator# 79520
city: Yaroslavl
country: Russian Federation
facility: Site Reference ID/Investigator# 83117
city: Yekaterinburg
country: Russian Federation
facility: Site Reference ID/Investigator# 97138
city: Brentford
country: United Kingdom
facility: Site Reference ID/Investigator# 81938
city: Edinburgh
country: United Kingdom
facility: Site Reference ID/Investigator# 81940
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 81939
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 92813
city: Newcastle upon Tyne
country: United Kingdom
facility: Site Reference ID/Investigator# 81937
city: Oxford
country: United Kingdom
facility: Site Reference ID/Investigator# 81943
city: Preston
country: United Kingdom
facility: Site Reference ID/Investigator# 82238
Study officials:
affiliation: AbbVie
name: George Haig, PharmD
role: STUDY_DIRECTOR
References:
citation: Haig G, Wang D, Othman AA, Zhao J. The alpha7 Nicotinic Agonist ABT-126 in the Treatment of Cognitive Impairment Associated with Schizophrenia in Nonsmokers: Results from a Randomized Controlled Phase 2b Study. Neuropsychopharmacology. 2016 Nov;41(12):2893-2902. doi: 10.1038/npp.2016.101. Epub 2016 Jun 20.
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.
citation: Bain EE, Shafner L, Walling DP, Othman AA, Chuang-Stein C, Hinkle J, Hanina A. Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia. JMIR Mhealth Uhealth. 2017 Feb 21;5(2):e18. doi: 10.2196/mhealth.7030.