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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: ABT-126; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01655680

2012-000418-13 (EudraCT Number)

M10-855

Details and patient eligibility

About

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

Full 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.

Enrollment: 432 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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432 participants in 4 patient groups, including a placebo group

ABT-126 Low Dose

Experimental group

Description:

ABT-126 Low Dose

Treatment:

Drug: ABT-126

Drug: ABT-126

Drug: ABT-126

ABT-126 Middle Dose

Experimental group

Description:

ABT-126 Middle Dose

Treatment:

Drug: ABT-126

Drug: ABT-126

Drug: ABT-126

ABT-126 High Dose

Experimental group

Description:

ABT-126 High Dose

Treatment:

Drug: ABT-126

Drug: ABT-126

Drug: ABT-126

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo