A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
1
2
3
4
5
6
7
8
9
ABT-288 vs placebo capsules administered orally once daily for 14 days
ABT-288 vs placebo capsules administered orally once daily for 14 days
ABT-288 vs placebo capsules administered orally once daily for 14 days
ABT288 vs placebo administered orally once daily for 14 days
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288 vs placebo administered orally once daily for 14 days