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

NCT02480400 | Completed

• 1 other identifier: Lu-Pl-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

MDD; Escitalopram; Placebo

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Montgomery Åsberg Depression Rating Scale

  Change from baseline to study completion in week 8.

Study Arms (2)

Supported Escitalopram

EXPERIMENTAL

Escitalopram, with assessment visits at baseline, and weeks 2, 4, 6 and 8

Drug: Escitalopram

Escitalopram

ACTIVE COMPARATOR

Escitalopram, with assessment visits at baseline, week 4 and week 8, and a safety visit at week 2

Drug: Escitalopram

Interventions

Escitalopram DRUG

Patients diagnosed with MDD and will fulfill the inclusion and exclusion criteria will start with escitalopram 10mg, according to the Summary of Product Characteristics. At week 2, patients with a baseline MADRS between 22 and 29 continue on 10mg, and patients with a baseline MADRS \> 30 receive a fixed dose 20mg until the end of treatment.

Also known as: Cipralex, Lexapro

Supported Escitalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients, men and women between 18 and 65 years of age (both extremes included)
• DSM IV-TR criteria for a current MDE lasting between 3 and 12 months
• Baseline MADRS total score \> 22

You may not qualify if:

• WHO-5 total score \> 13 or a score \> 3 on any single item of the WHO-5 (not revealed to the investigator)
• Other primary or co-primary psychiatric disorder which is more distressful for the patient than MDDD, as evaluated by investigator
• Patients with any history of mania/bipolar I disorder
• Patients using medications which are contraindicated with the use of escitalopram
• Known contraindication for the use of citalopram or escitalopram
• Patients that have not responded to 2 or more treatments with an adequate dose of an antidepressant for an adequate time
• Patients receiving formal behaviour therapy, or systematic psychotherapy
• Unable to understand or read Hebrew and give written informed consent
• Prominent suicidal ideation \> 5 on item 10 (suicidal thoughts) of the MADRS\]
• Alcohol or substance dependence in the past 6 months

Sponsors & Collaborators

• Abarbanel Mental Health Center: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Abarbanel MHC

Bat Yam, 59100, Israel

Location

Related Publications (1)

• 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.

  PMID: 19041717 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yehuda Baruch, MD, MHA

  Abarbanel MHC, Israel.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Psychogeriatrics

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 24, 2015
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

IL (1)