What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Cognitive Behavioral Therapy for Insomnia, or PET Scan with [11C]ABP688. The registry lists allocation as na. This is mechanistic clinical trial that evaluates the role of one of the glutamate receptors (mGluR5) in cognitive behavioral therapy for insomnia (CBT-I) as a common pathway in improving sleep and depression.
They plan to enroll about 42 people at Stony Brook. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Mechanistic Clinical Trial Evaluating the Role of the Metabotropic Glutamate Receptor Subtype 5 (mGluR5) in the Antidepressant Mechanism of Cognitive Behavioral Therapy for Insomnia (CBT-I)
Interventions: Cognitive Behavioral Therapy for Insomnia, PET Scan with [11C]ABP688
Primary outcome (registry wording): Change in Sleep Latency from Baseline to 8 Weeks