Light and Ion Maintenance In Treatment for Depression (LIMIT-D): Feasibility Study
Recruiting · NCT05423275 · Interventional (participants receive a specific treatment) · Lead sponsor: University of British Columbia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 achieve symptom remission, to prevent relapse but many people stop antidepressants too soon relapse into another depressive episode. We will test non-medication treatments, negative ion therapy and light therapy, to see they can substitute for antidepressants to prevent relapse. This is a "feasibility" study to see if participants use study treatments properly, before doing a larger, definitive trial. In this 28-week study, 100 participants with MDD who are in remission with antidepressants will be treated with light therapy or negative ion therapy (with half of devices active and half inactive) while slowly discontinuing the antidepressant, and monitored for relapse.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Djavad Mowafaghian Centre for Brain Health - Vancouver, British Columbia, Canada