Schizophrenia
Conditions
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.
Interventions
DRUGABT-288
See Arm Description for details.
DRUGPlacebo
See Arm Description for details.
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Extrapyramidal Symptom Rating Scale | Day -1, Day 14 |
| Columbia Suicide Severity Rating Scale | Screening, Day 15 |
| Pharmacodynamics: CANTAB & PANSS | Screening, Day -1, Day 14 |
| Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified | Day -1, Day 15 |
Outcome results
None listed