Safety and Efficacy Study for Cognitive Deficits in Adult Subjects With Schizophrenia



Status:Completed
Conditions:Cognitive Studies, Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:20 - 55
Updated:6/7/2018
Start Date:March 2010
End Date:September 2011

Use our guide to learn which trials are right for you!

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 and safety study evaluating an experimental treatment for cognitive
deficits in adults with schizophrenia.

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in
approximately 210 adults with schizophrenia. Subjects will be randomized to one of three
treatment groups (ABT-126 Dose 1, ABT-126 Dose 2 or placebo) for a 12-week Treatment Period.
The purpose of this research study is to find out whether ABT-126 compared to placebo can
improve cognition and what side effects ABT-126 may cause. Cognition is the way a person
thinks, and it includes abilities like paying attention, focusing, remembering things, and
solving problems. Acronyms listed in the Outcomes and/or Eligibility sections for this study
are defined below: • MCCB: Measurement and Treatment Research to Improve Cognition in
Schizophrenia (MATRICS) Consensus Cognitive Battery • UPSA-2: University of California at San
Diego (UCSD) Performance-Based Skills Assessment-2 • CANTAB: Cambridge Neuropsychological
Test Automated Battery • PANSS: Positive and Negative Syndrome Scale • NSA-16: Negative
Symptom Assessment-16 • CGI-S: Clinical Global Impression - Severity

Inclusion Criteria

- Has current DSM-IV-TR diagnosis of schizophrenia confirmed by the Mini-International
Neuropsychiatric Interview.

- Is clinically stable while receiving antipsychotic therapy with one or two atypical
antipsychotic medications: lack of hospitalizations from 4 months of Initial Screening
Visit; taking same antipsychotic medication(s) for at least 8 weeks prior to the Day
-1 visit; core positive symptoms of 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 responsible contact person (e.g., family member, social worker, case
worker, or nurse) that can provide support to the subject and ensure compliance with
protocol requirements.

Exclusion Criteria

- Has valid current or past diagnosis of schizoaffective disorder, bipolar disorder,
manic episode, dementia, posttraumatic stress disorder, obsessive compulsive disorder,
or a current major depressive episode.

- Has history of substance abuse (excluding nicotine or tobacco products) or alcohol
abuse within 6 months prior to Screening Visit; has a substance dependence disorder
(excluding nicotine or tobacco products) that has not been remitted for at least 1
year prior to Initial Screening Visit.

- Is taking any medication for extrapyramidal symptoms at any time from the Initial
Screening Visit until the Day -1 Visit.

- Is taking any antidepressant that is excluded, including tricyclic antidepressants and
monoamine oxidase inhibitors, at any time from 8 weeks prior to the Day -1 Visit.

- Has significant suicidal ideation at Initial Screening Visit.

- Has had a suicide attempt within 1 year prior to the Day -1 Visit.

- Has participated in another trial utilizing the MATRICS Consensus Cognitive Battery
(MCCB) or UCSD Performance-Based Skills Assessment (UPSA) (any version) within 6
months prior to Initial Screening Visit.

- Is currently enrolled in any form of cognitive remediation training.
We found this trial at
22
sites
2041
mi
from 91732
Beachwood, OH
Click here to add this to my saved trials
14
mi
from 91732
Cerritos, CA
Click here to add this to my saved trials
28
mi
from 91732
Costa Mesa, CA
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
86
mi
from 91732
Escondido, CA
Click here to add this to my saved trials
2443
mi
from 91732
Fresh Meadows, NY
Click here to add this to my saved trials
21
mi
from 91732
Garden Grove, CA
Click here to add this to my saved trials
Granada Hills, California 91344
31
mi
from 91732
Granada Hills, CA
Click here to add this to my saved trials
1471
mi
from 91732
Lake Charles, LA
Click here to add this to my saved trials
2363
mi
from 91732
Media, PA
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
2365
mi
from 91732
Norristown, PA
Click here to add this to my saved trials
73
mi
from 91732
Oceanside, CA
Click here to add this to my saved trials
2245
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
1573
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
San Bernardino, California 92408
43
mi
from 91732
San Bernardino, CA
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
24
mi
from 91732
Santa Ana, CA
Click here to add this to my saved trials
Sellersville, Pennsylvania 18960
2365
mi
from 91732
Sellersville, PA
Click here to add this to my saved trials
2136
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
24
mi
from 91732
Torrance, CA
Click here to add this to my saved trials
1182
mi
from 91732
Wichita, KS
Click here to add this to my saved trials