Condition category
Mental and Behavioural Disorders
Date applied
17/08/2009
Date assigned
20/08/2009
Last edited
20/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Raymond Lam

ORCID ID

Contact details

2C7 - 2255 Wesbrook Mall
Vancouver
V6T 2A1
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00958204

Protocol/serial number

MCT-94832; H09-01015

Study information

Scientific title

A randomised controlled trial of light therapy, negative ion therapy and fluoxetine in non-seasonal major depression

Acronym

Study hypothesis

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 non-seasonal 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 bright light or negative ion therapy is more effective than either monotherapy condition

Ethics approval

1. University of British Columbia: Clinical Research Ethics Board approved on the 5th June 2009 (ref: H09-01015)
2. Vancouver Coastal Health Authority: Vancouver Coastal Health Research Institute approved on the 17th June 2009 (ref: V09-0141)

Study design

Multicentre double-blind (subject and rater) randomised parallel-design trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Major depressive disorder

Intervention

1. Experimental: Light therapy/negative ion therapy (active) plus placebo pill
2. Experimental: Light therapy/negative ion therapy (active) plus fluoxetine 20 mg/day
3. Active Comparator: Light therapy/negative ion therapy (inactive) plus fluoxetine 20 mg/day
4. Placebo Comparator: Light therapy/negative ion therapy (inactive) plus placebo pill

Negative ion therapy: Ion generator emitting 4.5 x 10^14 ions/second for 30 minutes daily in the morning
Light therapy: 10,000 lux fluorescent light box for 30 minutes daily in the morning.

Note: Half of all devices used (light boxes and negative ion generators) will be inactive (placebo condition). Duration of treatment and follow-up: 8 weeks.

Intervention type

Drug

Phase

Phase III

Drug names

Fluoxetine

Primary outcome measures

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

Secondary outcome measures

At 2-month follow-up:
1. Clinical response and remission rates
2. Absenteeism and work productivity
3. Adverse events
4. Quality of life
5. Health services

Overall trial start date

01/09/2009

Overall trial end date

01/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female outpatients aged 19 - 60 years
2. Patients will meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for major depressive disorder as determined by the mood disorders section of the Mini International Neuropsychiatric Interview (MINI)
3. A score of 20 or greater on the Hamilton Depression Rating Scale (Ham-D), indicating at least moderately severe depression
4. Competency to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

216 over 3 years

Participant exclusion criteria

1. Pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception
2. Serious suicidal risks as judged by the clinician and the MINI
3. 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 generalised anxiety disorder, if a primary diagnosis; obsessive-compulsive disorder or post-traumatic stress disorder; bipolar disorder; bulimia nervosa or anorexia nervosa
4. Serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and haematologic disease that is not stabilised, or a past history of convulsions
5. Any retinal disease or systemic illness with active retinal involvement (e.g. diabetes) that precludes the use of bright light
6. Patients who have a history of severe allergies and multiple drug adverse reactions
7. Regular or current use of other psychotropic drugs, including lithium and tryptophan
8. Patients treated with beta blocking drugs
9. Hypertensive patients being treated with guanethidine, reserpine, clonidine or methyldopa (because of possible mood-altering effects of those drugs)
10. 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)
11. Previous use of fluoxetine or light therapy
12. 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
13. 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
14. Patients involved in any other form of treatment for depression

Recruitment start date

01/09/2009

Recruitment end date

01/03/2013

Locations

Countries of recruitment

Canada

Trial participating centre

2C7 - 2255 Wesbrook Mall
Vancouver
V6T 2A1
Canada

Sponsor information

Organisation

University of British Columbia (Canada)

Sponsor details

Office of Research Services
TEF III
#102-6190 Agronomy Road
Vancouver
V6T 1Z3
Canada

Sponsor type

University/education

Website

http://www.ubc.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-94832)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes