Major Depressive Disorder, Recurrent, in RemissionNCT05423275
Light and Ion Maintenance In Treatment for Depression (LIMIT-D): Feasibility Study
A study testing Negative ion therapy and Light therapy in people with Major Depressive Disorder, Recurrent, in Remission, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Recurrent, in Remission
- What is being tested?
- Negative ion therapy and Light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 13 Mar 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Djavad Mowafaghian Centre for Brain Health
Vancouver, British Columbia, V6T 2A1
Vanessa Evans, 604-822-8102, vanessa.evans@ubc.ca
Raymond W Lam, MD
About this study
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.
Read the 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 bi-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.
- Being tested
- Negative ion therapy, Light therapy
- Keywords
- antidepressants, discontinuation, relapse prevention, light therapy, negative ions, depression
- Medical subject headings
- Depressive Disorder, Major, Recurrence, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative ion therapyDevice
Negative ion generator
Light therapyDevice
Fluorescent light box
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The number of participants entered into the study during the recruitment period.
Measured: 36 months
Secondary outcomes (3)
Adherence to study treatment
Percentage of scheduled time that participants use the study treatment
Measured: 28 weeks
Rate of stopping antidepressants
Rate of success in tapering and discontinuing antidepressants
Measured: 8 weeks
All-cause dropout rate
Rate of dropouts from the study for any cause
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start13 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder, Recurrent, in RemissionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, two-group, parallel, relapse prevention design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Université de Montréal, Canadian Institutes of Health Research (CIHR), McMaster University, Ontario Brain Institute, Centre for Addiction and Mental Health
- Responsible party
- Principal investigator, Raymond Lam, University of British Columbia
- Investigators
- Raymond W Lam, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423275
- Sponsor's protocol ID
- H22-01067
- Status last verified
- Dec 2024
- First submitted
- 14 Jun 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light and Ion Maintenance In Treatment for Depression (LIMIT-D): Feasibility Study
- ClinicalTrials.gov ID
- NCT05423275
- Acronym / sponsor ID
- H22-01067
- Keywords
- antidepressants, discontinuation, relapse prevention, light therapy, negative ions, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Toronto, Université de Montréal, Canadian Institutes of Health Research (CIHR), McMaster University, Ontario Brain Institute, Centre for Addiction and Mental Health
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 bi-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, two-group, parallel, relapse prevention design
| Arm | Type | Receives |
|---|---|---|
| Negative ion therapy | Active comparator | Device: Negative ion therapyHigh 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. |
| Light therapy | Active comparator | Device: Light therapy4000 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative ion therapyNegative ion generator | Device | Negative ion therapy |
| Light therapyFluorescent light box | Device | Light therapy |
Primary outcome
Recruitment rate
Time frame: 36 months
The number of participants entered into the study during the recruitment period.
3 secondary outcomes
Adherence to study treatment
Time frame: 28 weeks
Rate of stopping antidepressants
Time frame: 8 weeks
All-cause dropout rate
Time frame: 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raymond W Lam, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative ion therapy and Light therapy in people with Major Depressive Disorder, Recurrent, in Remission, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Evans, BSc (604-822-8102, vanessa.evans@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.