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NCT06096207

DBS for Depression

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

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Record History

All 11 versions: 8 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Phase changed: Phase 1 → Not applicable Show 4 more changesShow less
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site contact updated
    • Publications: details revised at 3 of 3 entries
  2. Eligibility criteria expanded, about 33 wordsv7
  3. Eligibility criteria expanded, about 39 words
    • Secondary endpoints revised (3)
    • Site contact updated
    v6
  4. Eligibility criteria shortened, about 1 word
    • Site contact updated
    v5
  5. Trial status: Suspended to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Oct 18, 2024 to Oct 18, 2030
    • Eligibility criteria shortened, about 3 words
    • Study completion date: Oct 18, 2028 to Oct 18, 2038
    • Site details revised
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Recruiting to Suspended Sponsor's reason: Unanticipated problem observed.
    • Site details revised
    v3
  2. Eligibility criteria shortened, about 19 words
    • Site contact updated
    v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed

Endpoints

Primary

Montgomery-Asberg Depression Rating Scale (MADRS)
Timeframe: 12 months

Secondary (3)

World Health Organization Disability Assessment Scale 2.0 (WHODAS2.0)
Clinical Global Impressions (CGI) rated severity
Measuring MADRS during discontinuation cross over weeks

Arms and interventions

Discontinuation Phase Group 1Experimental

Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.

Discontinuation Phase Group 2Experimental

Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.

Devices: Medtronic SenSight Directional DBS lead

Sites

1 site in 1 country

  • Zucker Hillside HospitalQueens, New York, United States