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

NCT05423275 | Recruiting DMC

• 1 other identifier: H22-01067
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  The number of participants entered into the study during the recruitment period.

  36 months

Secondary Outcomes (3)

• Adherence to study treatment

  28 weeks

• Rate of stopping antidepressants

  8 weeks

• All-cause dropout rate

  28 weeks

Other Outcomes (4)

• Time to relapse

  28 weeks

• Relapse rate

  28 weeks

• Adverse events

  28 weeks

Study Arms (2)

Negative ion therapy

ACTIVE COMPARATOR

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.

Device: Negative ion therapy

Light therapy

ACTIVE COMPARATOR

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.

Device: Light therapy

Interventions

Negative ion therapy DEVICE

Negative ion generator

Negative ion therapy

Light therapy DEVICE

Fluorescent light box

Light therapy

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• University of Toronto: collaborator
• Université de Montréal: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• McMaster University: collaborator
• Ontario Brain Institute: collaborator
• Centre for Addiction and Mental Health: collaborator

Study Sites (1)

Djavad Mowafaghian Centre for Brain Health

Vancouver, British Columbia, V6T 2A1, Canada

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence; Depression

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Raymond W Lam, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Evans, BSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant and the clinical outcome assessor is masked as to whether the study device is active or inactive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, two-group, parallel, relapse prevention design

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: March 13, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CA (1)