Status:
RECRUITING
Light and Ion Maintenance In Treatment for Depression (LIMIT-D): Feasibility Study
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
University of Toronto
Université de Montréal
Conditions:
Major Depressive Disorder, Recurrent, in Remission
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
Antidepressants are widely used as first-line treatments for major depressive disorder (MDD). Clinical guidelines recommend 6-24 months of "maintenance" antidepressant treatment, after patients achiev...
Detailed Description
The purpose of this study is to evaluate the feasibility of a multicentre, randomized, trial of light therapy and negative ion therapy as substitutes for antidepressants for maintenance treatment for ...
Eligibility Criteria
Inclusion
- Diagnostic and Statistical Manual (DSM-5) criteria for MDD, as determined by the Structured Clinical Interview for DSM-5 (SCID).
- Taking a first-line antidepressant at approved doses (Table 1), with dose unchanged in the past month.
- Participant desire to discontinue antidepressant treatment because of adverse effects or other reasons;
- In remission as defined by score ≤10 on the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) at both the screening visit and baseline visit, at least 2 weeks apart.
- Willing and able to complete self-report and online assessments including sufficient fluency in English or French.
Exclusion
- Any psychiatric diagnosis other than MDD that is considered the primary diagnosis, including Bipolar I or Bipolar-II (lifetime). Note that comorbid anxiety disorders (e.g., generalized anxiety disorder, social anxiety disorder) will not be excluded if the anxiety disorder is not the primary diagnosis.
- Diagnosis of MDD with seasonal pattern (i.e., seasonal affective disorder, SAD) or with psychotic features (lifetime).
- Significant personality disorder diagnosis \[e.g., antisocial\] by MINI and clinical assessment.
- High suicidal risk, defined by clinician judgment.
- History of alcohol or substance use disorder, with a severity of at least moderate or severe, within 6 months before screening.
- Significant neurological disorders, head trauma, or other unstable medical conditions.
- Regular use of psychotropic medication other than an antidepressant or benzodiazepines (e.g., antipsychotics, mood stabilizers); Note - Stimulant medications for Attention-Deficit Hyperactivity Disorder are allowed if dose is stable in past month.
- History of severe antidepressant discontinuation effects.
- Retinal disease or other eye condition (e.g., macular degeneration) precluding the use of bright light treatment.
- Use of photosensitizing medication (thioridazine, chloroquine, 8-methoxypsoralen) within 1 week of baseline visit.
- Initiated formal psychotherapy (e.g., cognitive-behavioural therapy) within 3 months of Visit 1, or who plan to initiate psychotherapy during the study.
- Continued use of any other evidence-based treatment for depression.
Key Trial Info
Start Date :
March 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05423275
Start Date
March 13 2023
End Date
June 1 2027
Last Update
December 9 2024
Active Locations (1)
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1
Djavad Mowafaghian Centre for Brain Health
Vancouver, British Columbia, Canada, V6T 2A1