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PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 316 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 21 versions Re-verified since Feb 28, 2024, no change to tracked fieldsv296-v316
  2. Primary completion date: May 29, 2025 to Oct 3, 2029
    • Study completion date: Aug 29, 2025 to Apr 11, 2030
    v295
  3. 5 versions Re-verified since Oct 19, 2023, no change to tracked fieldsv290-v294
  4. Eligibility criteria shortened, about 44 wordsv289
  5. 3 versions Re-verified since Jun 3, 2023, no change to tracked fieldsv286-v288
Show 19 earlier versionsHide 19 earlier versions
  1. Eligibility criteria shortened, about 2 wordsv285
  2. Eligibility criteria shortened, about 9 wordsv284
  3. Re-verified, no change to tracked fieldsv283
  4. Eligibility criteria expanded, about 15 wordsv282
  5. 4 versions Re-verified since Sep 22, 2022, no change to tracked fieldsv278-v281
  6. Study description shortened, about 197 wordsv277
  7. Eligibility criteria shortened, about 11 words
    • Study description shortened, about 3 words
    v276
  8. Re-verified, no change to tracked fieldsv275
  9. Primary completion date: May 29, 2023 to May 29, 2025
    • Study completion date: Aug 29, 2023 to Aug 29, 2025
    v274
  10. 7 versions Re-verified since Jun 24, 2022, no change to tracked fieldsv267-v273
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Researchers developed \[11C\]MC1, a radioligand for cyclooxygenase-2 (COX-2). COX-2 is an enzyme induced in the brain during inflammation. Researchers want to see the levels of COX-1 (measured as distribution volume VT) are elevated in the brain of two groups of mood disorders patients undergoing MDE relative to the control group. Objective: To determine whether COX-1 and COX-2 are detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE). Eligibility: People aged 18-70 years with MDD and Healthy Volunteers aged 18 70 years. Design: Group A: MDD participants will be studied with the same dose of \[11C\]MC1 before and after administration of 600 mg celecoxib; the study is neither randomized nor placebo-controlled. Group B: MDD participants, both medicated and unmedicated, will be studied with \[11C\]PS13 and compared to healthy volunteers.. https://nimhcontent.nimh.nih.gov/start/surveys/?s=TJW4RA4WN3LDD988
Trial Details
NCT Number NCT04582916
Lead Sponsor National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Depression
Related terms Depression, Inflammation
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov