ong-Term Safety and Efficacy of ABT-126 in Subjects with Schizophrenia: A Double-Blind Extension Study for Subjects Completing Study M10-855

Phase 1

Conditions: Cognitive deficits in schizophrenia
MedDRA version: 17.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2012-005661-13-GB

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 430

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 430
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to obtain long-term safety, efficacy and health outcomes data in patients with schizophrenia.;Secondary Objective: Not applicable.;Primary end point(s): Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB);Timepoint(s) of evaluation of this end point: From Day -1 to Week 52

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER);Timepoint(s) of evaluation of this end point: From Week 24 of M10-855 to Week 52