Major Depression in RemissionNCT04944758

Feasibility of Adherence to Light Therapy

A study testing Light therapy in people with Major Depression in Remission, run by University of British Columbia at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

In this feasibility study, we propose an important question: What factors will affect participant adherence to the daily use of light therapy for maintenance treatment of depression? To answer this question, we will conduct a pilot study of open-label treatment with light therapy in a small sample (n=10) of… Read more about this study

Who is it for?: Ages 19 to 65 years
Conditions the study is for: Major Depression in Remission
What is being tested?: Light therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteCanada
Study dates: 21 Apr 2022to 21 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

[1] Outpatients 19 to 65 years of age;
[2] Diagnostic and Statistical Manual (DSM)-5 criteria for major depressive disorder (MDD) past or recurrent episode as determined by the Mini International Neuropsychiatric Interview;
[3] taking an antidepressant for no more than six months;
[4] participant desire to discontinue antidepressant treatment because of adverse effects or other reasons;
[5] total score ≤10 on the clinician-rated Montgomery-Asberg Depression Rating Scale [MADRS];
[6] Willing and able to complete self-report and online assessments including sufficient fluency in English.

Who cannot join

[1] Any psychiatric diagnosis other than MDD that is considered the primary diagnosis, including Bipolar I or Bipolar-II (lifetime);
[2] MDD with psychotic features (lifetime);
[3] significant personality disorder diagnosis [e.g., borderline, antisocial];
[4] High suicidal risk, defined by clinician judgment;
[5] History of drug or alcohol abuse, with a severity of at least moderate or severe within 6 months before screening;
[6] Significant neurological disorders, head trauma, or other unstable medical conditions;

Show all 10Show fewer

[7] regular use of psychotropic medication other than an antidepressant or benzodiazepines (e.g., antipsychotics, mood stabilizers);
[8] history of severe withdrawal effects with antidepressant discontinuation;
[9] retinal disease or other eye condition preventing use of bright light therapy;
[10] use of photosensitizing medication within 1 week of baseline visit.

Trial locations and contacts

1 site in 1 country.

Canada1 site

UBC Mood Disorders Centre
Vancouver, British Columbia, V6T1Z3

Other trials in Canada

About this study

Official title: A Feasibility Study of Adherence to Light Therapy for Maintenance Treatment of Major Depressive Disorder

Read the detailed description

Guidelines recommend at least 6-9 months of maintenance treatment to prevent relapse once patients with major depressive disorder (MDD) are in symptom remission with antidepressant treatment. However, many patients decide to discontinue antidepressants because of side effects or personal preference for a non-pharmacological treatment. Hence, a priority question for patients is whether non-pharmacological treatments can be substituted for antidepressants for maintenance treatment.

Light therapy is a safe, evidence-based, non-pharmacological treatment for MDD and seasonal affective disorder (SAD) with fewer side effects than antidepressants. The safety and efficacy of light therapy suggest that it would also be effective for maintenance treatment and relapse prevention, but there are no studies addressing this question.

Before conducting a randomized controlled trial, we want to determine whether light therapy is feasible for patients in remission with antidepressants and whether patients will adhere to standard light therapy protocols. In this feasibility study, we will enroll patients with MDD in remission who wish to discontinue their antidepressant and substitute open-label light therapy to examine adherence outcomes.

Conditions: Major Depression in Remission
Being tested: Light therapy
Keywords: major depressive disorder, light therapy, relapse prevention, adherence
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Light therapyDevice
Light therapy

Study groups in NCT04944758
Study group	Role	What they receive
Light therapy	Other	Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication. Receives: Device: Light therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Adherence Rate
Rate of adherence (>75% of total daily sessions) to light therapy
Measured: 6 weeks

Secondary outcomes (4)

Relapse Rate
Relapse as defined.
Measured: 6 weeks
Change in Clinician-rated Depressive Symptoms
Changes in MADRS scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Montgomery-Asberg Depression Rating Scale. MADRS scores range from 0 to 60, with higher scores indicating greater severity of depression (worse outcome).
Measured: 6 weeks
Change in Patient-rated Depressive Symptoms
Changes in scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Quick Inventory of Depressive Symptomatology, Self-Rated scale (QIDS-SR). The QIDS-SR scores range from 0 to 27, with higher scores indicating greater severity of depression (worse outcome).
Measured: 6 weeks
Discontinuation Symptoms
Scores on a discontinuation effects scale developed for this study, Antidepressant Discontinuation Symptoms Scale (ADSS). Scores range from 0 to 117, with higher scores indicating more severe discontinuation symptoms (worse outcome).
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 202221 Jun 2022

First posted30 Jun 2021
Study start21 Apr 2022
Primary completion21 Jun 2022
Study completion21 Jun 2022

Why it stopped: We received a grant for an expanded feasibility trial that superseded this one.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depression 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: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Open-label feasibility study
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04944758
Sponsor's protocol ID: V2.0_May-17-2021
Status last verified: May 2024
First submitted: 14 Jun 2021
Last updated: 30 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Randomized, 52-Week Extension Study to Evaluate the Maintenance of Remission, Relapse Prevention, and Long-Term Safety of CreNeuroS™ in Patients With Major Depressive Disorder Who Achieved Remission Following an 8-Week Parent Study
Adjunct in the Treatment of Depressive Disorder
Active, not recruitingObservational study
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.2 (Stress Manipulation)
Major Depression in Remission
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Recruiting
Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference
Major Depressive Disorder, Recurrent, in Remission, Major Depressive Disorder, Recurrent, Mild
RecruitingObservational study
Predictors of Relapse in Major Depressive Disorder (PERFORM-D)
Major Depressive Disorder (MDD)

All Major Depression in Remission trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study of Adherence to Light Therapy for Maintenance Treatment of Major Depressive Disorder
ClinicalTrials.gov ID: NCT04944758
Acronym / sponsor ID: V2.0_May-17-2021
Conditions: Major Depression in Remission
Keywords: major depressive disorder, light therapy, relapse prevention, adherence
Study type: Interventional
Recruitment status: TerminatedReason stopped: We received a grant for an expanded feasibility trial that superseded this one.
Enrolment: 1 participants (actual)
Lead sponsor: University of British ColumbiaUniversity, hospital or other
Collaborators: Michael Smith Foundation for Health Research
Study start: 21 Apr 2022 (actual)
Primary completion: 21 Jun 2022 (actual)
Study completion: 21 Jun 2022 (actual)
First posted: 30 Jun 2021 (actual)
Results: Posted 30 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open-label feasibility study

Arm	Type	Receives
Light therapy	Other	Device: Light therapyDaily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

[1] Outpatients 19 to 65 years of age;
[2] Diagnostic and Statistical Manual (DSM)-5 criteria for major depressive disorder (MDD) past or recurrent episode as determined by the Mini International Neuropsychiatric Interview;
[3] taking an antidepressant for no more than six months;
[4] participant desire to discontinue antidepressant treatment because of adverse effects or other reasons;
[5] total score ≤10 on the clinician-rated Montgomery-Asberg Depression Rating Scale [MADRS];

Key exclusion criteria (10 listed)

[1] Any psychiatric diagnosis other than MDD that is considered the primary diagnosis, including Bipolar I or Bipolar-II (lifetime);
[2] MDD with psychotic features (lifetime);
[3] significant personality disorder diagnosis [e.g., borderline, antisocial];
[4] High suicidal risk, defined by clinician judgment;
[5] History of drug or alcohol abuse, 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
Light therapyLight therapy	Device	Light therapy

Primary outcome

Adherence Rate
Time frame: 6 weeks
Rate of adherence (>75% of total daily sessions) to light therapy

4 secondary outcomes

Relapse Rate
Time frame: 6 weeks
Change in Clinician-rated Depressive Symptoms
Time frame: 6 weeks
Change in Patient-rated Depressive Symptoms
Time frame: 6 weeks
Discontinuation Symptoms
Time frame: 4 weeks

Results and safety

Results posted to the registry on 30 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Light Therapy	1	1

Primary outcome: Adherence Rate

Time frame: 6 weeks. Number. Unit: participants

Measure	Light Therapy n = 1
Value	1

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Light Therapy	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Major Depression in Remission

Recruiting
A Randomized, 52-Week Extension Study to Evaluate the Maintenance of Remission, Relapse Prevention, and Long-Term Safety of CreNeuroS™ in Patients With Major Depressive Disorder Who Achieved Remission Following an 8-Week Parent Study
Adjunct in the Treatment of Depressive Disorder
Active, not recruitingObservational study
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.2 (Stress Manipulation)
Major Depression in Remission
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Recruiting
Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference
Major Depressive Disorder, Recurrent, in Remission, Major Depressive Disorder, Recurrent, Mild
RecruitingObservational study
Predictors of Relapse in Major Depressive Disorder (PERFORM-D)
Major Depressive Disorder (MDD)

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. This study is not recruiting at the moment.

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 Light therapy in people with Major Depression 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 30 May 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?

Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence Rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944758.

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 30 May 2024.