Clinical trial NCT02978599: Clinical Trial of AVL-3288 in Schizophrenia Patients
Official title: Double Blind, Two Dose, Cross-over Clinical Trial of the Positive Allosteric Modulator at the alpha7 Nicotinic Cholinergic Receptor AVL-3288 in Schizophrenia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2016-12-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
timeFrame: End of each 5-day treatment phase
Secondary outcomes:
measure: RBANS index T-score subscales
timeFrame: End of each 5-day treatment phase
measure: Brief Psychiatric Rating Scale (BPRS) Total score
timeFrame: End of each 5-day treatment phase
measure: Calgary Depression Rating Scale (CDRS) Total score
timeFrame: End of each 5-day treatment phase
measure: Scale for the Assessment of Negative Symptoms (SANS) Total score
timeFrame: End of each 5-day treatment phase
measure: P50 suppression measured by electroencephalographic (EEG)
timeFrame: End of each 5-day treatment phase
measure: Intensity of hippocampal BOLD fMRI signal during MRI scan
timeFrame: end of each 5-day treatment phase
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Jeffrey A Lieberman, MD
role: PRINCIPAL_INVESTIGATOR
References: