Schizophrenia
Conditions
Keywords
schizophrenia
Brief summary
This is a study of ABT-126 in the treatment of cognitive impairment associated with schizophrenia (CIAS), a long-term extension study to study M10-855 (NCT01655680).
Interventions
DRUGABT-126
capsule(s)
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
* The subject was randomized into Study M10-855 and completed through Week 26 in that study. * The subject is receiving one or more antipsychotic medications.
Exclusion criteria
* Additional history collected during participation in Study M10-855 provides evidence that, in the investigator's judgement, the subject does not have schizophrenia. * The subject experienced an adverse event or abnormal finding during physical examination, vital signs, laboratory profile, and/or electrocardiogram (ECG) measurements in Study M10-855 that indicates the subject is likely to become medically unstable during the current study. * The subject is currently taking or is expected to be prescribed any excluded medication without the approval of AbbVie medical monitor. * The subject is currently enrolled in, or plans to participate in, another interventional study during the course of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in electrocardiogram (ECG) data | from Day -1 to Week 52 |
| Percentage of subjects with adverse events | up to 52 weeks |
| Change in laboratory test results | from Day -1 to Week 52 |
| Change in vital signs | from Day -1 to Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | from Day -1 to Week 52 | rater based interview |
| Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER) | from Day -1 to Week 52 | rater based interview to evaluate functioning |
| Change in the Positive and Negative Syndrome Scale (PANSS) | from Day -1 to Week 52 | rater based interview to assess functioning |
| Change in the 16-item version of the Negative Symptom Assessment Scale (NSA-16) | from Day -1 to Week 52 | rater based interview to assess symptom severity |
Countries
Russia, United Kingdom, United States
Outcome results
None listed