Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;