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Trial record 73 of 532 for:    ESCITALOPRAM AND Disorders

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

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ClinicalTrials.gov Identifier: NCT02480400
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : June 24, 2015
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Yoram Barak, Abarbanel Mental Health Center

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram Not Applicable

Detailed Description:

This study is designed to determined if trial design, in the form of the frequency of patient contact (assessment visit numbers) has an effect on the efficacy outcome after 8-week treatment with escitalopram.

The placebo response is a major issue in clinical trials for psychiatric disorders-and especially in the management of depression. Possible contributing factors to this problem include diagnostic misclassification, issues concerning inclusion/exclusion criteria, outcome measures' lack of sensitivity to change, measurement errors, poor quality of data entry and verification, waxing and waning of the natural course of depression, regression toward the mean phenomenon, patient and clinician expectations about the trial, study design issues, non-specific therapeutic effects, and high attrition.

Over the past few decades, researchers have attempted to reduce the placebo effect in a variety of ways. Unfortunately, approaches with very little or no benefit have included restricting enrollment to selected populations, rater training, requirement of same rater, and placebo lead-in phases. Some benefits, although often marginal, have been derived from standardizing diagnostic procedures, managing clinicians' overestimation of change, simplification of study visits and assessments, minimizing nonspecific, therapeutic effects, extending trial duration, reducing number of sites, increasing the sensitivity of outcome measures, and reducing the number of treatment arms.

Thus far, there has been no attempt to develop new study designs aimed at reducing the placebo effect.

We are proposing a novel study design, suitable for doubleblind, trials in mood disorders. This design is aimed at characterizing and identifying both the overall placebo response rate and the sample size required for such


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Effect of Patient and Investigator Expectation on the Efficacy of Escitalopram in the Treatment of Patients With Major Depressive Disorder.
Study Start Date : June 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supported Escitalopram
Escitalopram, with assessment visits at baseline, and weeks 2, 4, 6 and 8
Drug: Escitalopram
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.
Other Name: Cipralex, Lexapro

Active Comparator: Escitalopram
Escitalopram, with assessment visits at baseline, week 4 and week 8, and a safety visit at week 2
Drug: Escitalopram
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.
Other Name: Cipralex, Lexapro




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


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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480400


Locations
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Israel
Abarbanel MHC
Bat-Yam, Israel, 59100
Sponsors and Collaborators
Abarbanel Mental Health Center
H. Lundbeck A/S
Investigators
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Study Chair: Yehuda Baruch, MD, MHA Abarbanel MHC, Israel.

Publications:
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Responsible Party: Yoram Barak, Director of Psychogeriatrics, Abarbanel Mental Health Center
ClinicalTrials.gov Identifier: NCT02480400     History of Changes
Other Study ID Numbers: Lu-Pl-001
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by Yoram Barak, Abarbanel Mental Health Center:
MDD
Escitalopram
Placebo

Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Depression
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents