Light and Ion Maintenance In Treatment for Depression (LIMIT-D): Feasibility Study
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
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
Treatments tested in this trial
- Negative ion therapy
- Light therapy
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
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