Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia
Completed · Phase 1 · Has a placebo group
Conditions studied: Schizophrenia
In brief
A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.
Key facts
- Study ID
- NCT01043458
- Run by
- Abbott
- People needed
- 16
- Starts
- 2009-11-01
- Last updated by the study team
- 2010-11-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject has signed informed consent;
- Current diagnosis of schizophrenia;
- Clinically stable on the same single second-generation (atypical) antipsychotic for the past 8 weeks;
- Meets study-specific criteria for Positive and Negative Syndrome Scale (PANSS);
- Females are not pregnant, not breast-feeding;
- Females are post-menopausal or surgically sterile or practicing birth control;
- Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control
You may not qualify if…
- Diagnosis of schizoaffective disorder;
- Diagnosis with mental retardation;
- Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
- Acute psychosis hospitalization within past 6 months;
- Bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, or drug-induced psychosis or current major depressive disorder;
- Current clozapine treatment;
- Suicidal ideation or behavior;
- BMI of 39 or greater;
- Relevant drug sensitivity or allergy;
- Positive hepatitis or HIV test result; positive urine screen for drugs of abuse or alcohol;
- Recent clinically significant illness/infection or surgery;
- Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
Where it is running
- Site Reference ID/Investigator# 25423 — Glendale, California, United States
- Site Reference ID/Investigator# 24322 — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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