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

Summary

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.

Conditions

• Major Depressive Disorder (MDD)

Interventions

DRUG

Placebo

Placebo Pill: one oral tablet each day, for 8 weeks.

DRUG

Fluoxetine

Fluoxetine: 20 mg oral tablet each day, for 8 weeks

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.

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

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• University of British Columbia

  lead OTHER

Principal Investigators

• Serge Beaulieu, Dr. · McGill University

• Amy HY Cheung, Dr. · University of Toronto

• Alexander J. Kiss, Dr. · Sunnybrook Health Sciences Centre

• Robert D. Levitan, Dr. · University of Toronto

• Anthony J. Levitt, Dr. · University of Toronto

• Erin E. Michalak, Dr. · University of British Columbia

• Rachel L. Morehouse, Dr. · Dalhousie University

• Sagar V. Parikh, Dr. · University of Toronto

• Rajamannar Ramasubbu, Dr. · University of Calgary

• Glenda MacQueen, Dr. · University of Calgary

• Raymond W. Lam, MD, FRCPC · University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2014-02-28

Completion

2014-05-31

Countries

• Canada

Study Locations