Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT00958204
Eligibility Criteria:
Inclusion Criteria:
* Male and female outpatients aged 19-60 years.
* Patients will meet DSM-IV criteria for major depressive disorder as determined by the mood disorders section of the Mini International Neuropsychiatric Interview (MINI, Sheehan et al, 1998).
* A score of 20 or greater on the Hamilton Depression Rating Scale (Ham-D), indicating at least moderately severe depression.
* Competency to give informed consent.
Exclusion Criteria:
* Pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception.
* Serious suicidal risks as judged by the clinician and the MINI.
* 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 generalized anxiety disorder, if a primary diagnosis; obsessive-compulsive disorder or post-traumatic stress disorder; bipolar disorder; bulimia nervosa or anorexia nervosa.
* Serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and hematologic disease that is not stabilized, or a past history of convulsions.
* Any retinal disease or systemic illness with active retinal involvement (e.g. diabetes) that precludes the use of bright light.
* Patients who have a history of severe allergies and multiple drug adverse reactions.
* Regular or current use of other psychotropic drugs, including lithium and tryptophan.
* Patients treated with beta blocking drugs.
* Hypertensive patients being treated with guanethidine, reserpine, clonidine or methyldopa (because of possible mood-altering effects of those drugs).
* 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).
* Previous use of fluoxetine or light therapy.
* 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.
* 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.
* Patients involved in any other form of treatment for depression.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
60 Years
Study:
NCT00958204
Study Brief:
Protocol Section:
NCT00958204