A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
Status: | Completed |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 20 - 55 |
Updated: | 11/23/2013 |
Start Date: | August 2012 |
End Date: | February 2014 |
Contact: | Julie Fugate, BS |
Email: | julie.m.fugate@abbvie.com |
Phone: | 847-938-5423 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
This is an efficacy study evaluating a experimental treatment for cognitive deficits in
adults with schizophrenia.
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.
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)
We found this trial at
18
sites
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