A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
Status and phase
Completed
Phase 1
Conditions
Schizophrenia
Treatments
Drug: Placebo
Drug: ABT-288
Details and patient eligibility
About
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.
Enrollment
81 patients
Sex
All
Ages
18 to 60 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
Double Blind
81 participants in 9 patient groups
1
Experimental group
Description:
ABT-288 vs placebo capsules administered orally once daily for 14 days
Treatment:
Drug: Placebo
Drug: ABT-288
2
Experimental group
Description:
ABT-288 vs placebo capsules administered orally once daily for 14 days
Treatment:
Drug: Placebo
Drug: ABT-288
3
Experimental group
Description:
ABT-288 vs placebo capsules administered orally once daily for 14 days
Treatment:
Drug: Placebo
Drug: ABT-288
4
Experimental group
Description:
ABT288 vs placebo administered orally once daily for 14 days
Treatment:
Drug: Placebo
Drug: ABT-288
5
Experimental group
Description:
ABT-288 vs placebo administered orally once daily for 14 days
Treatment:
Drug: Placebo
Drug: ABT-288
6
Experimental group
Description:
ABT-288 vs placebo administered orally once daily for 14 days
Treatment:
Drug: Placebo
Drug: ABT-288
7
Experimental group
Description:
ABT-288 vs placebo administered orally once daily for 14 days
Treatment:
Drug: Placebo
Drug: ABT-288
8
Experimental group
Description:
ABT-288 vs placebo administered orally once daily for 14 days
Treatment:
Drug: Placebo
Drug: ABT-288
9
Experimental group
Description:
ABT-288 vs placebo administered orally once daily for 14 days
Treatment:
Drug: Placebo
Drug: ABT-288
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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