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

Primary Purpose

Major Depressive Disorder, Recurrent, in Remission

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Negative ion therapy
Light therapy
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder, Recurrent, in Remission focused on measuring antidepressants, discontinuation, relapse prevention, light therapy, negative ions, depression

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnostic and Statistical Manual (DSM-5) criteria for MDD, recurrent episodes (two or more), as determined by the Mini International Neuropsychiatric Interview (MINI).
  • Taking a first-line antidepressant at approved doses (Table 1) for 3-12 months, 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).
  • 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.

Sites / Locations

  • Djavad Mowafaghian Centre for Brain HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Negative ion therapy

Light therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adherence to study treatment
Percentage of scheduled time that participants use the study treatment
Rate of stopping antidepressants
Rate of success in tapering and discontinuing antidepressants
All-cause dropout rate
Rate of dropouts from the study for any cause

Full Information

First Posted
June 14, 2022
Last Updated
August 2, 2023
Sponsor
University of British Columbia
Collaborators
University of Toronto, Université de Montréal, Canadian Institutes of Health Research (CIHR), McMaster University, Ontario Brain Institute, Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT05423275
Brief Title
Light and Ion Maintenance In Treatment for Depression (LIMIT-D): Feasibility Study
Official Title
Light and Ion Maintenance In Treatment for Depression (LIMIT-D): Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
University of Toronto, Université de Montréal, Canadian Institutes of Health Research (CIHR), McMaster University, Ontario Brain Institute, Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 recurrent 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.
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 patients with recurrent major depressive disorder (MDD). The study design for this feasibility study mirrors the full LIMIT-D protocol: a 28-week, double-blind (participant and outcome rater) relapse prevention study with 100 participants randomized 1:1 to one of two study treatments, light therapy or negative ion therapy, and assessed for relapse over 28 weeks. Half the study devices are modified to be inactive. After 2 weeks of study treatment, the participant's antidepressant will be tapered and discontinued between Week 2 and Week 8. Participants are assessed for relapse at each scheduled study visit (every 2 weeks during antidepressant taper until week 8, then every 4 weeks until end of study treatment at Week 28) by blind outcome raters. In addition, they complete an online Personal Health Questionnaire (PHQ-9) self-rated depression symptom scale weekly; if total score is 10 or higher OR the suicide item score is 2 or higher, participants are booked for a relapse-assessment visit and relapse-verification study visit at least 1 week apart. Relapse will be defined as any of the following: MADRS total score 20 or higher for at least 2 consecutive weeks and Diagnostic and Statistical Manual (DSM-5) criteria for major depressive episode at the Relapse-Verification visit. Hospitalization for worsening of depression. Suicidal ideation with intent or plan, or suicidal behaviour. Any change in treatment for depression (e.g., starting an antidepressant). At each visit, clinician-rated and self-rated symptom, side effect, and functioning measures are completed. The primary feasibility outcome is recruitment rate; secondary feasibility outcomes include adherence to study treatment, successful discontinuation of antidepressants rate, and all-cause dropout rate. Secondary clinical outcomes include relapse rate, time to relapse, adverse events, and safety profiles. Participants will wear an actigraph at home during the 28-week study treatment period to assess sleep, light and activity/circadian rhythms. There is a final observational visit by Zoom videoconference at Week 52.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Recurrent, in Remission
Keywords
antidepressants, discontinuation, relapse prevention, light therapy, negative ions, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, two-group, parallel, relapse prevention design
Masking
ParticipantOutcomes Assessor
Masking Description
Participant and the clinical outcome assessor is masked as to whether the study device is active or inactive.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Negative ion therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Light therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Negative ion therapy
Intervention Description
Negative ion generator
Intervention Type
Device
Intervention Name(s)
Light therapy
Intervention Description
Fluorescent light box
Primary Outcome Measure Information:
Title
Recruitment rate
Description
The number of participants entered into the study during the recruitment period.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Adherence to study treatment
Description
Percentage of scheduled time that participants use the study treatment
Time Frame
28 weeks
Title
Rate of stopping antidepressants
Description
Rate of success in tapering and discontinuing antidepressants
Time Frame
8 weeks
Title
All-cause dropout rate
Description
Rate of dropouts from the study for any cause
Time Frame
28 weeks
Other Pre-specified Outcome Measures:
Title
Time to relapse
Description
Time to protocol-defined relapse, based on survival analysis
Time Frame
28 weeks
Title
Relapse rate
Description
Rate of relapses, based on survival analysis
Time Frame
28 weeks
Title
Adverse events
Description
Number and severity of adverse events
Time Frame
28 weeks
Title
Serious adverse events
Description
Number of serious adverse events including hypomanic mood switch
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnostic and Statistical Manual (DSM-5) criteria for MDD, recurrent episodes (two or more), as determined by the Mini International Neuropsychiatric Interview (MINI). Taking a first-line antidepressant at approved doses (Table 1) for 3-12 months, 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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Evans, BSc
Phone
604-822-8102
Email
vanessa.evans@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond W Lam, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Djavad Mowafaghian Centre for Brain Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2A1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Evans
Phone
604-822-8102
Email
vanessa.evans@ubc.ca
First Name & Middle Initial & Last Name & Degree
Raymond W Lam, MD

12. IPD Sharing Statement

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

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