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Chronotherapy for Depressive Episodes

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Jan 2026 to Jan 2029
    • Eligibility criteria expanded, about 4 words
    v7
  2. Minor Eligibility criteria shortened, about 1 wordv6
  3. Minor Re-verified, no change to tracked fieldsv5
  4. Minor Secondary endpoints: 53 to 60v4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2023 to Apr 12, 2023
    • Site details revised
    v3
  6. Minor Start date: Jan 2023 to Mar 2023
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 57 to 53
    v2
  7. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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Evidence-based treatments for depression, such as antidepressive medication, usually have a latency of 4 to 6 weeks before they achieve a therapeutic effect. Chronotherapy is a group of non-pharmacological interventions that presumably act on the circadian system to achieve a rapid-onset clinical effect and better long-term effects and has been shown efficient to improve depressive symptoms. Interventions include sleep deprivation, sleep-phase advancement and stabilization, and light therapy. There are few studies testing the effectiveness of combining these three chronotherapeutic techniques in the initial phase of treatment of depression in a mental health care clinic. The investigators aim to test the effects and safety of chronotherapy in addition to TAU compared to TAU alone, with the primary outcome being self-reported depressive symptoms at 1 week following randomization. The study is a randomized controlled trial with 76 patients with a depressive episode who initiate treatment at Nidaros DPS, St. Olavs University Hospital. Participants will be allocated 1:1 to either chronotherapy + treatment as usual (TAU) or to TAU alone.
Trial Details
NCT Number NCT05691647
Lead Sponsor St. Olavs Hospital
Conditions
(from sponsor)
Depressive Episode
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov