Status:
COMPLETED
A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
Lead Sponsor:
AbbVie
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00888693
Start Date
November 1 2008
Last Update
November 21 2017
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