Major Depressive Disorder Clinical Trial
Official title:
The Effect of Patient and Investigator Expectation on the Efficacy of Escitalopram in the Treatment of Patients With Major Depressive Disorder.
Verified date | June 2015 |
Source | Abarbanel Mental Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
To evaluate the effect of visit number, patient expectation, and rater expectation of the efficacy of escitalopram treatment in fixed doses of 10 and 20mg, based on baseline severity in patients with MDD.
Status | Completed |
Enrollment | 52 |
Est. completion date | October 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Outpatients, men and women between 18 and 65 years of age (both extremes included) 2. DSM IV-TR criteria for a current MDE lasting between 3 and 12 months 3. Baseline MADRS total score > 22 Exclusion Criteria: 1. WHO-5 total score > 13 or a score > 3 on any single item of the WHO-5 (not revealed to the investigator) 2. Other primary or co-primary psychiatric disorder which is more distressful for the patient than MDDD, as evaluated by investigator 3. Patients with any history of mania/bipolar I disorder 4. Patients using medications which are contraindicated with the use of escitalopram 5. Known contraindication for the use of citalopram or escitalopram 6. Patients that have not responded to 2 or more treatments with an adequate dose of an antidepressant for an adequate time 7. Patients receiving formal behaviour therapy, or systematic psychotherapy 8. Unable to understand or read Hebrew and give written informed consent 9. Prominent suicidal ideation > 5 on item 10 (suicidal thoughts) of the MADRS] 10. Alcohol or substance dependence in the past 6 months |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Israel | Abarbanel MHC | Bat-Yam |
Lead Sponsor | Collaborator |
---|---|
Abarbanel Mental Health Center | H. Lundbeck A/S |
Israel,
Gomeni R, Lavergne A, Merlo-Pich E. Modelling placebo response in depression trials using a longitudinal model with informative dropout. Eur J Pharm Sci. 2009 Jan 31;36(1):4-10. doi: 10.1016/j.ejps.2008.10.025. Epub 2008 Nov 8. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sheehan Disability Scale | The Sheehan Disability Scale (Sheehan 1983) is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by panic, anxiety, phobic, or depressive symptoms. This scale has been used widely in psychopharmacology randomized controlled trials, particularly for panic disorder. This anchored visual analog scale uses spatiovisual, numeric, and verbal descriptive anchors simultaneously to assess disability across three domains: work, social life, and family life. | Change from baseline to study completion by week 8. | No |
Secondary | Montgomery Åsberg Depression Rating Scale | This is a 10-item checklist. Widely used in drug-treatment trials, mainly because of its particular sensitivity to treatment effects. Since there is a comparative lack of emphasis on somatic symptoms, the scale is useful for the assessment of depression in people with physical illness. | Change from baseline to study completion in week 8. | No |
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