RightFit
RecruitingPhase 4

The Role of mGluR5 in CBT-I

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * capacity to provide informed consent, * at least 18 years of age * good physical health and absence of significant medical conditions, * diagnosis of major depressive disorder (MDD) with current major depressive episode as per DSM-5 criteria * Montgomery-Åsberg Depression Rating Scale (MADRS) score \> 29 (at least moderate depression), * uniform range of sleep latencies up to 128 minutes. Exclusion Criteria: * currently taking effective antidepressants, * lifetime history of psychosis, * drug or alcohol dependence in the last 6 months or abuse in the last 2 months * unstable medical condition (i.e., condition not adequately stabilized for ≥ 3 months) * nicotine use within 1 year * currently on medication known to affect glutamate, * sleep disorders, other than insomnia, such as sleep apnea, * recent (within 1 year) regular night shift work (or rotating shift work) or recent (within 3 months) travel across more than one time zone, or plans for this work or travel during the study period, * use of medication or substances that affect sleep, for example, ingestion of more \> 600 mg of caffeine per day, * PET or MRI contraindications, including pregnancy or currently breastfeeding

Study sites (1)

NY