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ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response

Study acronym: NORLIGHT
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 26 to 28
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 3 of 7 entries
  2. Site details revised at 3 of 26 sitesv12
  3. Trial sites expanded: 23 → 26 locationsv11
  4. Primary endpoint(s) modified
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: 1 to 7
    v10
  5. Study sites: 21 to 23v9
  6. Trial sites expanded: 16 → 21 locationsv8
  7. Trial sites expanded: 13 → 16 locationsv7
  8. Study sites: 12 to 13v6
  9. Study sites: 8 to 12v5
  10. Study sites: 6 to 8v4
  11. Eligibility criteria shortened, about 700 wordsv3
  12. Study sites: 2 to 6v2
  13. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD). The main questions the study aims to answer are: * Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression? * What adverse events do participants have when taking ACP-211?
Trial Details
NCT Number NCT07284667
Lead Sponsor ACADIA Pharmaceuticals Inc.
Conditions
(from sponsor)		 Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Related terms Depressive Disorder, Treatment-Resistant, Major Depressive Disorder
Enrollment 153 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov