Recruiting

Light Therapy & Negative Ion Therapy

Sponsor:

University of British Columbia

Code:

NCT05423275

Conditions

Major Depressive Disorder, Recurrent, in Remission

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

Interventions

Negative ion therapy

Light therapy

Study Details

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 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.

Conditions

Major Depressive Disorder, Recurrent, in Remission

Study ID

NCT05423275

Start date

Mar 13, 2023

Status verified date

Dec, 2024

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Negative ion therapy

High density negative ions at 3.4 trillion ions per second with no detectable ozone, used for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am.

active comparator: Light therapy

4000 Kelvin white fluorescent light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter, used for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am.

Interventions

Negative ion therapy

Negative ion generator

Light therapy

Fluorescent light box

Primary outcome measure

  • Recruitment rate [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Vanessa Evans, BSc

604-822-8102vanessa.evans@ubc.ca

Locations

Djavad Mowafaghian Centre for Brain Health

Recruiting

Vancouver, British Columbia, Canada, V6T 2A1

Contacts

Vanessa Evans

604-822-8102vanessa.evans@ubc.ca

Principal Investigator:

Raymond W Lam, MD

More Information

Sponsor

University of British Columbia

Last update posted

Dec 9, 2024

Last verified

Dec, 2024

Keywords

  • antidepressants
  • discontinuation
  • relapse prevention
  • light therapy
  • negative ions
  • depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-12-09.