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| Sponsor: | University of British Columbia |
|---|---|
| Collaborator: |
Canadian Institutes of Health Research (CIHR) |
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00958204 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Light and Ion Treatment to Enhance Medication Efficacy in Depression |
| Estimated Enrollment: | 216 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
|
2: Experimental
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
|
|
3: Active Comparator
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
|
|
4: Placebo Comparator
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cindy Woo | 604-822-7627 | cinw@interchange.ubc.ca |
| Canada, British Columbia | |
| UBC Hospital Mood Disorders Centre | Recruiting |
| Vancouver, British Columbia, Canada, V6T 2A1 | |
| Contact: Cindy Woo 604-822-7627 cinw@interchange.ubc.ca | |
| 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 |
More Information
| Responsible Party: | University of British Columbia ( Dr. Raymond W. Lam, MD, FRCPC ) |
| Study ID Numbers: | H09-01015 |
| Study First Received: | August 11, 2009 |
| Last Updated: | October 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00958204 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Depression rating scales RCT combination treatment |
light therapy negative ion therapy fluoxetine antidepressants |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions |
Behavioral Symptoms Fluoxetine Serotonin Agents Mental Disorders Therapeutic Uses Mood Disorders Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |