ISRCTN10003823CompletedPhase 3
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 enrollmentStarted: August 20, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 216
Study 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)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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