A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
- Registration Number
- NCT00888693
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 4 ABT-288 ABT288 vs placebo administered orally once daily for 14 days 4 Placebo ABT288 vs placebo administered orally once daily for 14 days 3 Placebo ABT-288 vs placebo capsules administered orally once daily for 14 days 2 Placebo ABT-288 vs placebo capsules administered orally once daily for 14 days 5 Placebo ABT-288 vs placebo administered orally once daily for 14 days 1 Placebo ABT-288 vs placebo capsules administered orally once daily for 14 days 6 Placebo ABT-288 vs placebo administered orally once daily for 14 days 7 Placebo ABT-288 vs placebo administered orally once daily for 14 days 8 Placebo ABT-288 vs placebo administered orally once daily for 14 days 9 Placebo ABT-288 vs placebo administered orally once daily for 14 days 2 ABT-288 ABT-288 vs placebo capsules administered orally once daily for 14 days 7 ABT-288 ABT-288 vs placebo administered orally once daily for 14 days 1 ABT-288 ABT-288 vs placebo capsules administered orally once daily for 14 days 3 ABT-288 ABT-288 vs placebo capsules administered orally once daily for 14 days 5 ABT-288 ABT-288 vs placebo administered orally once daily for 14 days 6 ABT-288 ABT-288 vs placebo administered orally once daily for 14 days 8 ABT-288 ABT-288 vs placebo administered orally once daily for 14 days 9 ABT-288 ABT-288 vs placebo administered orally once daily for 14 days
- Primary Outcome Measures
Name Time Method Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests, Days -1 to 21 Pharmacokinetics; optional CSF for arms 7, 8 & 9 Days -1 to 21
- Secondary Outcome Measures
Name Time Method Columbia Suicide Severity Rating Scale Screening, Day 15 Extrapyramidal Symptom Rating Scale Day -1, Day 14 Pharmacodynamics: CANTAB & PANSS Screening, Day -1, Day 14 Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified Day -1, Day 15