Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase, cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of AVL-3288 each compared to placebo, in patients with schizophrenia.
Detailed description
This study will be in 24 non-smoking outpatients with schizophrenia or schizoaffective disorder. Subjects will complete three treatment phases, each involving 5 straight days of taking AVL-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in which subjects do not take the study drug to ensure that the drug is completed eliminated from the body before the next phase.
Interventions
DRUGAVL-3288
daily for 5 days
DRUGPlacebo
daily for 5 days
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* DSM-V diagnosis of schizophrenia or schizoaffective disorder * RBANS Total Scale Score \>62 * Willing to provide informed consent * Medically stable for study participation * Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks * Judged clinically not to be at significant suicide or violence risk
Exclusion criteria
* Substance abuse (excluding nicotine) within last 90 days * ECG abnormality that is clinically significant * Current clozapine use * Participation in a study of investigational medication/device within 4 weeks * Pregnancy, lactation, or lack of use of effective birth control * Active tobacco use * Presence or positive history of significant medical or neurological illness, including cardiac illness, WBC \<3500/mm3, absolute neutrophil count \<1500/mm3, ALT or AST values \>1.5 times upper limit of normal. Hemoglobin less than 130 g/L (13 g/dL) in males or 120 g/L (12 g/dL) in females or known HIV + * Contraindication to MRI scanning, including metal implants or claustrophobia * Medicinal patch, unless removed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score | End of each 5-day treatment phase | Compare effect of active drug (AVL-3288) to placebo on RBANS total score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Psychiatric Rating Scale (BPRS) Total score | End of each 5-day treatment phase | Compare effect of active drug (AVL-3288) to placebo on BPRS Total Score. |
| Calgary Depression Rating Scale (CDRS) Total score | End of each 5-day treatment phase | Compare effect of active drug (AVL-3288) to placebo on CDRS Total Score. |
| RBANS index T-score subscales | End of each 5-day treatment phase | Compare effect of active drug (AVL-3288) to placebo on RBANS index T-score subscales |
| P50 suppression measured by electroencephalographic (EEG) | End of each 5-day treatment phase | Compare P50 suppression measured by EEG between active drug (AVL-3288) and placebo |
| Intensity of hippocampal BOLD fMRI signal during MRI scan | end of each 5-day treatment phase | Compare intensity of Hippocampal BOLD signal between active drug (AVL-3288) and placebo |
| Scale for the Assessment of Negative Symptoms (SANS) Total score | End of each 5-day treatment phase | Compare effect of active drug (AVL-3288) to placebo on SANS Total score |
Countries
United States
Outcome results
None listed