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

niversity of British Columbia (Canada)0 sites216 target enrollmentAugust 20, 2009

ConditionsMajor depressive disorder Mental and Behavioural Disorders Depressive episode

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Major depressive disorder
Sponsor: niversity of British Columbia (Canada)
Enrollment: 216
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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)

Registry

who.int

Start Date

August 20, 2009

End Date

March 1, 2013

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity of British Columbia (Canada)

Eligibility Criteria

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\)