Clinical Trial of AVL-3288 in Schizophrenia Patients
- Conditions
- SchizophreniaSchizoaffective Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT02978599
- Lead Sponsor
- New York State Psychiatric Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AVL-3288 10 mg AVL-3288 AVL-3288 10 mg daily for 5 days AVL-3288 30 mg AVL-3288 AVL-3288 30 mg daily for 5 days Placebo Placebo Placebo daily for 5 days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
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
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.
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
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
Trial Locations
- Locations (1)
New York State Psychiatric Institute
🇺🇸New York, New York, United States