Light, Ion, and Fluoxetine Efficacy (LIFE) in Depression

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00958204
First received: August 11, 2009
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

This study will investigate the additional benefits of light and ion therapy as added treatments to an antidepressant (fluoxetine) in subjects with major depressive disorder (MDD), versus treatment with fluoxetine alone. Outcomes will include depressive symptom rating scales and measures of quality of life, work absence and productivity, and use of health care services. The primary hypotheses are that, in patients with nonseasonal major depressive disorder (MDD) of at least moderate severity: 1) bright light therapy or negative ion therapy will be superior to a placebo condition in reducing symptoms of depression, and 2) the combination of fluoxetine and either bright light or negative ion therapy is more effective than either monotherapy condition.


Condition Intervention Phase
Major Depressive Disorder (MDD)
Procedure: Light treatment
Procedure: Negative ion therapy
Drug: Placebo
Drug: Fluoxetine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Light and Ion Treatment to Enhance Medication Efficacy in Depression

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change in adjusted HAM-D scores at 2-month follow-up. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • At 2-month follow-up: clinical response and remission rates, absenteeism and work productivity, adverse events, quality of life, and health services. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: October 2009
Study Completion Date: May 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Light treatment using a fluorescent light box (30 minutes daily) plus a placebo pill every day
Procedure: Light treatment
Light therapy: from a 10,000 lux fluorescent white light box, for 30 minutes per day upon waking in the morning, for 8 weeks.
Drug: Placebo
Placebo Pill: one oral tablet each day, for 8 weeks.
Experimental: 2
Negative ion generator (30 minutes daily) plus 20 mg of fluoxetine per day
Procedure: Negative ion therapy
Negative ion therapy: from a negative ion generator with an output of 200 trillion ions per second per cubic centimeter, for 30 minutes per day upon waking in the morning, for 8 weeks
Drug: Fluoxetine
Fluoxetine: 20 mg oral tablet each day, for 8 weeks
Active Comparator: 3
Light treatment using a fluorescent light box (30 minutes daily) plus 20 mg of fluoxetine per day
Procedure: Light treatment
Light therapy: from a 10,000 lux fluorescent white light box, for 30 minutes per day upon waking in the morning, for 8 weeks.
Drug: Fluoxetine
Fluoxetine: 20 mg oral tablet each day, for 8 weeks
Placebo Comparator: 4
Negative ion generator (30 minutes daily) plus placebo pill every day
Procedure: Negative ion therapy
Negative ion therapy: from a negative ion generator with an output of 200 trillion ions per second per cubic centimeter, for 30 minutes per day upon waking in the morning, for 8 weeks
Drug: Placebo
Placebo Pill: one oral tablet each day, for 8 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female outpatients aged 19-60 years.
  • Patients will meet DSM-IV criteria for major depressive disorder as determined by the mood disorders section of the Mini International Neuropsychiatric Interview (MINI, Sheehan et al, 1998).
  • A score of 20 or greater on the Hamilton Depression Rating Scale (Ham-D), indicating at least moderately severe depression.
  • Competency to give informed consent.

Exclusion Criteria:

  • Pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception.
  • Serious suicidal risks as judged by the clinician and the MINI.
  • The following DSM-IV diagnoses (to ensure a homogeneous diagnostic group): organic mental disorders; substance abuse/dependence, including alcohol, active within the last year; schizophrenia, paranoid, or delusional disorders; other psychotic disorders; panic disorder or generalized anxiety disorder, if a primary diagnosis; obsessive-compulsive disorder or post-traumatic stress disorder; bipolar disorder; bulimia nervosa or anorexia nervosa.
  • Serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and hematologic disease that is not stabilized, or a past history of convulsions.
  • Any retinal disease or systemic illness with active retinal involvement (e.g. diabetes) that precludes the use of bright light.
  • Patients who have a history of severe allergies and multiple drug adverse reactions.
  • Regular or current use of other psychotropic drugs, including lithium and tryptophan.
  • Patients treated with beta blocking drugs.
  • Hypertensive patients being treated with guanethidine, reserpine, clonidine or methyldopa (because of possible mood-altering effects of those drugs).
  • Use of monoamine oxidase inhibitors within 14 days of Visit 1 (to ensure no drug interactions between fluoxetine and MAOIs), or use of heterocyclic antidepressants within 7 days of Visit 1 (to ensure adequate washout period of two weeks between stopping previous drug and start of treatment at Visit 2).
  • Previous use of fluoxetine or light therapy.
  • Treatment resistance in the current episode, as defined by failure (lack of clinically significant response) of two or more antidepressants given at therapeutic doses for at least 6 weeks.
  • Patients who start formal psychotherapy (e.g. cognitive-behavioural or interpersonal psychotherapy) within 3 months of Visit 1, or who plan to initiate such psychotherapy during this study.
  • Patients involved in any other form of treatment for depression.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958204

Locations
Canada, British Columbia
UBC Hospital Mood Disorders Centre
Vancouver, British Columbia, Canada, V6T 2A1
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Study Director: Serge Beaulieu, Dr. McGill University
Study Director: Amy HY Cheung, Dr. University of Toronto
Study Director: Alexander J. Kiss, Dr. Sunnybrook Health Sciences Centre
Study Director: Robert D. Levitan, Dr. University of Toronto
Study Director: Anthony J. Levitt, Dr. University of Toronto
Study Director: Erin E. Michalak, Dr. University of British Columbia
Study Director: Rachel L. Morehouse, Dr. Dalhousie University
Study Director: Sagar V. Parikh, Dr. University of Toronto
Study Director: Rajamannar Ramasubbu, Dr. University of Calgary
Study Director: Glenda MacQueen, Dr. University of Calgary
Principal Investigator: Raymond W. Lam, MD, FRCPC University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00958204     History of Changes
Other Study ID Numbers: H09-01015
Study First Received: August 11, 2009
Last Updated: June 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Depression
rating scales
RCT
combination treatment
light therapy
negative ion therapy
fluoxetine
antidepressants

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014