The Effect of Patient and Investigator Expectation on the Efficacy of Escitalopram in the Treatment Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02480400
• Date of registration: 22/06/2015
• Prospective Registration: No
• Primary sponsor: Abarbanel Mental Health Center
• Public title: The Effect of Patient and Investigator Expectation on the Efficacy of Escitalopram in the Treatment Depression
• Scientific title: The Effect of Patient and Investigator Expectation on the Efficacy of Escitalopram in the Treatment of Patients With Major Depressive Disorder.
• Date of first enrolment: June 2010
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02480400
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Yehuda Baruch, MD, MHA
• Affiliation: Abarbanel MHC, Israel.

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: Escitalopram

Primary Outcome(s)

Sheehan Disability Scale [Time Frame: Change from baseline to study completion by week 8.]

Secondary Outcome(s)

Montgomery Åsberg Depression Rating Scale [Time Frame: Change from baseline to study completion in week 8.]

Secondary ID(s)

Lu-Pl-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

H. Lundbeck A/S