ight and Ion Treatment to Enhance Medication Efficacy in Depressio

Phase 3

Completed

• Conditions: Major depressive disorder; Mental and Behavioural Disorders; Depressive episode

• Registration Number: ISRCTN10003823
• Lead Sponsor: niversity of British Columbia (Canada)

Brief Summary

1. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/26580307 (added 29/01/2019) 2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30063303 (added 29/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-20
• Study Completion: 2013-03-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 216

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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