Light, Ion, and Fluoxetine Efficacy (LIFE) in Depression
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ClinicalTrials.gov Identifier: NCT00958204 |
Recruitment Status :
Completed
First Posted : August 13, 2009
Last Update Posted : June 6, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder (MDD) | Procedure: Light treatment Procedure: Negative ion therapy Drug: Placebo Drug: Fluoxetine | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 134 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Light and Ion Treatment to Enhance Medication Efficacy in Depression |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
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. |
- Change in adjusted HAM-D scores at 2-month follow-up. [ Time Frame: 2 months ]
- 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 ]

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Ages Eligible for Study: | 19 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958204
Canada, British Columbia | |
UBC Hospital Mood Disorders Centre | |
Vancouver, British Columbia, Canada, V6T 2A1 |
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 |
Responsible Party: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00958204 |
Other Study ID Numbers: |
H09-01015 |
First Posted: | August 13, 2009 Key Record Dates |
Last Update Posted: | June 6, 2014 |
Last Verified: | June 2014 |
Depression rating scales RCT combination treatment |
light therapy negative ion therapy fluoxetine antidepressants |
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Fluoxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |