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

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT01678755

Run by

AbbVie (prior sponsor, Abbott)

People needed

157

Starts

2012-08-01

Expected to finish

2014-03-01

Last updated by the study team

2021-07-07

Who can join

Age: 20 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Site Reference ID/Investigator# 74436 — Chino, California, United States
• Site Reference ID/Investigator# 72704 — Garden Grove, California, United States
• Site Reference ID/Investigator# 72699 — National City, California, United States
• Site Reference ID/Investigator# 73983 — Oceanside, California, United States
• Site Reference ID/Investigator# 73236 — Orange, California, United States
• Site Reference ID/Investigator# 86974 — San Diego, California, United States
• Site Reference ID/Investigator# 72701 — Torrance, California, United States
• Site Reference ID/Investigator# 75314 — Bradenton, Florida, United States
• Site Reference ID/Investigator# 75146 — Maitland, 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# 76534 — Hoffman Estates, Illinois, United States
• Site Reference ID/Investigator# 73984 — Lake Charles, Louisiana, United States
• Site Reference ID/Investigator# 73981 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 89553 — Marlton, New Jersey, United States
• Site Reference ID/Investigator# 72700 — Cedarhurst, New York, United States
• Site Reference ID/Investigator# 73982 — New York, New York, United States
• Site Reference ID/Investigator# 113035 — Oklahoma City, Oklahoma, United States
• Site Reference ID/Investigator# 72702 — DeSoto, Texas, United States
• Site Reference ID/Investigator# 75147 — Houston, Texas, United States

Full record on ClinicalTrials.gov

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