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New treatment option for Major Depressive Disorder (MDD)
Official title The Role of mGluR5 in CBT-I
ClinicalTrials.gov ID: NCT07076342
What this study is testing
What is PET Scan with [11C]ABP688?
PET Scan with [11C]ABP688 is an investigational medicine, being studied as a potential treatment for major depressive disorder (mdd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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),
You likely can't join if
- 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,
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Stony Brook, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stony Brook, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.