Schizophrenia Clinical Trial
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
| Verified date | July 2021 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a safety and efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.
| Status | Completed |
| Enrollment | 432 |
| Est. completion date | July 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 65 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 |
|---|---|---|---|
| Russian Federation | Site Reference ID/Investigator# 94476 | Chita | |
| Russian Federation | Site Reference ID/Investigator# 79515 | Ekaterinburg | |
| Russian Federation | Site Reference ID/Investigator# 94528 | Kazan | |
| Russian Federation | Site Reference ID/Investigator# 79517 | Lipetsk | |
| Russian Federation | Site Reference ID/Investigator# 79516 | Moscow | |
| Russian Federation | Site Reference ID/Investigator# 81934 | Moscow | |
| Russian Federation | Site Reference ID/Investigator# 81935 | Moscow | |
| Russian Federation | Site Reference ID/Investigator# 83116 | Novosibirsk | |
| Russian Federation | Site Reference ID/Investigator# 97136 | Saint-Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 79514 | Saratov | |
| Russian Federation | Site Reference ID/Investigator# 81933 | Saratov | |
| Russian Federation | Site Reference ID/Investigator# 80673 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 83115 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 84733 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 85093 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 97135 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 97137 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 79520 | Stavropol | |
| Russian Federation | Site Reference ID/Investigator# 83117 | Yaroslavl | |
| Russian Federation | Site Reference ID/Investigator# 97138 | Yekaterinburg | |
| United Kingdom | Site Reference ID/Investigator# 81938 | Brentford | |
| United Kingdom | Site Reference ID/Investigator# 81940 | Edinburgh | |
| United Kingdom | Site Reference ID/Investigator# 81939 | London | |
| United Kingdom | Site Reference ID/Investigator# 92813 | London | |
| United Kingdom | Site Reference ID/Investigator# 81937 | Newcastle upon Tyne | |
| United Kingdom | Site Reference ID/Investigator# 81943 | Oxford | |
| United Kingdom | Site Reference ID/Investigator# 82238 | Preston | |
| United States | Site Reference ID/Investigator# 75139 | Anaheim | California |
| United States | Site Reference ID/Investigator# 75653 | Atlanta | Georgia |
| United States | Site Reference ID/Investigator# 74894 | Bellflower | California |
| United States | Site Reference ID/Investigator# 72694 | Cedarhurst | New York |
| United States | Site Reference ID/Investigator# 72697 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 74434 | Chino | California |
| United States | Site Reference ID/Investigator# 76593 | Costa Mesa | California |
| United States | Site Reference ID/Investigator# 74553 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 72696 | DeSoto | Texas |
| United States | Site Reference ID/Investigator# 73213 | Escondido | California |
| United States | Site Reference ID/Investigator# 72698 | Garden Grove | California |
| United States | Site Reference ID/Investigator# 76533 | Hoffman Estates | Illinois |
| United States | Site Reference ID/Investigator# 74896 | Houston | Texas |
| United States | Site Reference ID/Investigator# 75055 | Houston | Texas |
| United States | Site Reference ID/Investigator# 75057 | La Habra | California |
| United States | Site Reference ID/Investigator# 74893 | Marietta | Georgia |
| United States | Site Reference ID/Investigator# 72693 | National City | California |
| United States | Site Reference ID/Investigator# 75136 | New Haven | Connecticut |
| United States | Site Reference ID/Investigator# 77655 | Norwalk | California |
| United States | Site Reference ID/Investigator# 74895 | Oakland | California |
| United States | Site Reference ID/Investigator# 73977 | Oceanside | California |
| United States | Site Reference ID/Investigator# 73214 | Orange | California |
| United States | Site Reference ID/Investigator# 75413 | Philadelphia | Pennsylvania |
| United States | Site Reference ID/Investigator# 74453 | Pico Rivera | California |
| United States | Site Reference ID/Investigator# 74898 | Riverside | California |
| United States | Site Reference ID/Investigator# 75137 | Rochester | New York |
| United States | Site Reference ID/Investigator# 98016 | San Bernardino | California |
| United States | Site Reference ID/Investigator# 75140 | San Diego | California |
| United States | Site Reference ID/Investigator# 86973 | San Diego | California |
| United States | Site Reference ID/Investigator# 73974 | San Gabriel | California |
| United States | Site Reference ID/Investigator# 74433 | Santa Ana | California |
| United States | Site Reference ID/Investigator# 75053 | Staten Island | New York |
| United States | Site Reference ID/Investigator# 72695 | Torrance | California |
| United States | Site Reference ID/Investigator# 75056 | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
United States, Russian Federation, United Kingdom,
Haig G, Wang D, Othman AA, Zhao J. The a7 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):2893-29 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cognition: MCCB (MATRICS Consensus Cognitive Battery) | Rater based interview | Change from baseline to week 24 | |
| Secondary | Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2) | Rater based interview | Measurements from screening period up through week 24 | |
| Secondary | Symptom Severity: PANSS (Positive and Negative Symptom Scale) | Rater based interview | Measurements from screening period up through week 24 | |
| Secondary | Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale) | Rater based interview | Measurements from screening period up through week 24 |
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