Schizophrenia
Conditions
Keywords
Schizophrenia
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.
Interventions
DRUGABT-126
ABT-126 Middle Dose
DRUGPlacebo
Placebo
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognition: MCCB (MATRICS Consensus Cognitive Battery) | Change from baseline to week 24 | Rater based interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2) | Measurements from screening period up through week 24 | Rater based interview |
| Symptom Severity: PANSS (Positive and Negative Symptom Scale) | Measurements from screening period up through week 24 | Rater based interview |
| Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale) | Measurements from screening period up through week 24 | Rater based interview |
Countries
Russia, United Kingdom, United States
Outcome results
None listed