A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia

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

Summary

Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.

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

Details

• Lead Sponsor: Abbott; AbbVie

Criteria

Inclusion Criteria:

• Subject has signed informed consent;

• Current DSM-IV-TR diagnosis of schizophrenia;

• Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;

• Meets study-specific PANSS criteria;

• Willing and able to cooperate with cognitive testing

• 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:

• Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;

• Diagnosis of schizoaffective disorder;

• Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;

• Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;

• Current clozapine treatment; suicidal ideation or behavior;

• BMI of 39 or greater; current homicidal or violent ideation;

• Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;

• Positive hepatitis or HIV test result;

• Recent clinically significant illness/infection or surgery;

• Recent blood product transfusion, donation or loss of 5 mL/kg of blood;

• Visual, hearing or communication disability