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

ConditionMajor Depressive Disorder, Recurrent, in Remission

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19-65

SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Negative ion therapy
Device
Negative ion generator
Light therapy
Device
Fluorescent light box

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Negative ion therapyActive comparator 1 intervention

Group B: Light therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Recruitment rate

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

Time frame

36 months

Secondary outcomes

Adherence to study treatment

Percentage of scheduled time that participants use the study treatment

Time frame

28 weeks

Rate of stopping antidepressants

Rate of success in tapering and discontinuing antidepressants

Time frame

8 weeks

All-cause dropout rate

Rate of dropouts from the study for any cause

Time frame

28 weeks

Other outcomes

Time to relapse

Time to protocol-defined relapse, based on survival analysis

Time frame

28 weeks

Relapse rate

Rate of relapses, based on survival analysis

Time frame

28 weeks

Adverse events

Number and severity of adverse events

Time frame

28 weeks

Serious adverse events

Number of serious adverse events including hypomanic mood switch

Time frame

28 weeks

Sponsors and contacts

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University of British Columbia

Lead sponsor

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

Source ClinicalTrials.gov

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