Using light and negative ion therapy to prevent depression relapse

Light and Ion Maintenance In Treatment for Depression (LIMIT-D): Feasibility Study

This study is testing whether light therapy and negative ion therapy can help people with recurrent depression stay well after stopping their antidepressants.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 19 Years to 65 Years
• Sex: All
• Sponsor: University of British Columbia (other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT05423275 on ClinicalTrials.gov

What this trial studies

This feasibility study aims to evaluate the use of light therapy and negative ion therapy as alternatives to antidepressants for maintaining remission in patients with recurrent major depressive disorder (MDD). Over 28 weeks, 100 participants currently in remission will gradually taper off their antidepressants while receiving one of the two therapies. The study will assess the feasibility of these non-medication treatments in preventing relapse, with participants monitored bi-weekly for depressive symptoms and relapse. The study is designed to inform a larger, definitive trial based on the findings.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with recurrent major depressive disorder who are currently in remission and wish to discontinue their antidepressant treatment.

Not a fit: Patients with primary psychiatric diagnoses other than major depressive disorder, such as bipolar disorder, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide patients with effective non-medication options to maintain their mental health and prevent relapse.

How similar studies have performed: While the specific combination of light and negative ion therapy is novel, similar studies exploring non-medication treatments for depression have shown promising results.

Eligibility criteria

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 this trial is running

Vancouver, British Columbia

• Djavad Mowafaghian Centre for Brain Health — Vancouver, British Columbia, Canada (RECRUITING)

Study contacts

• Principal investigator: Raymond W Lam, MD — University of British Columbia
• Study coordinator: Vanessa Evans, BSc

Conditions: Major Depressive Disorder, Recurrent, in Remission, antidepressants, discontinuation, relapse prevention, light therapy, negative ions, depression