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

NCT00958204 | Completed Phase 3 DMC

• 1 other identifier: H09-01015
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Depression; rating scales; RCT; combination treatment; light therapy; negative ion therapy; fluoxetine; antidepressants

Outcome Measures

Primary Outcomes (1)

• Change in adjusted HAM-D scores at 2-month follow-up.

  2 months

Secondary Outcomes (1)

• At 2-month follow-up: clinical response and remission rates, absenteeism and work productivity, adverse events, quality of life, and health services.

  2 months

Study Arms (4)

1

EXPERIMENTAL

Light treatment using a fluorescent light box (30 minutes daily) plus a placebo pill every day

Procedure: Light treatment; Drug: Placebo

2

EXPERIMENTAL

Negative ion generator (30 minutes daily) plus 20 mg of fluoxetine per day

Procedure: Negative ion therapy; Drug: Fluoxetine

3

ACTIVE COMPARATOR

Light treatment using a fluorescent light box (30 minutes daily) plus 20 mg of fluoxetine per day

Procedure: Light treatment; Drug: Fluoxetine

4

PLACEBO COMPARATOR

Negative ion generator (30 minutes daily) plus placebo pill every day

Procedure: Negative ion therapy; Drug: Placebo

Interventions

Light treatment PROCEDURE

Light therapy: from a 10,000 lux fluorescent white light box, for 30 minutes per day upon waking in the morning, for 8 weeks.

1; 3

Negative ion therapy PROCEDURE

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

2; 4

Placebo DRUG

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

1; 4

Fluoxetine DRUG

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

2; 3

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

UBC Hospital Mood Disorders Centre

Vancouver, British Columbia, V6T 2A1, Canada

Location

Related Publications (2)

• Levitan RD, Levitt AJ, Michalak EE, Morehouse R, Ramasubbu R, Yatham LN, Tam EM, Lam RW. Appetitive Symptoms Differentially Predict Treatment Response to Fluoxetine, Light, and Placebo in Nonseasonal Major Depression. J Clin Psychiatry. 2018 Jul 24;79(4):17m11856. doi: 10.4088/JCP.17m11856.

  PMID: 30063303 DERIVED

• Lam RW, Levitt AJ, Levitan RD, Michalak EE, Cheung AH, Morehouse R, Ramasubbu R, Yatham LN, Tam EM. Efficacy of Bright Light Treatment, Fluoxetine, and the Combination in Patients With Nonseasonal Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jan;73(1):56-63. doi: 10.1001/jamapsychiatry.2015.2235.

  PMID: 26580307 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• 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

  STUDY DIRECTOR

• Raymond W. Lam, MD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 6, 2014

Record last verified: 2014-06

Locations

CA (1)