The Effect of Patient and Investigator Expectation on the Efficacy of Escitalopram in the Treatment Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

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.
    

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
    

Intervention name(s): Escitalopram; Escitalopram
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Cipralex, Lexapro; Cipralex, Lexapro
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: MDD; Escitalopram; Placebo