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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list