Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders

Study Overview
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Brief Summary
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Escitalopram has been approved by FDA in the treatment of adolescents with major depressive disorder since March 2009. To date, there are only 3 clinical trials assessing the effect and validity of escitalopram on major depressive disorder, which of them has resulted in inconsistent findings. In the present study, the authors aimed to assess the effect and validity of this drug in the treatment of adolescents with major depressive disorder and or anxiety disorders.

Detailed Description
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Escitalopram has been approved by FDA in the treatment of adolescents with major depressive disorder since March 2009. Although Wagner and colleagues reported that escitalopram has a tendency toward positive findings for the treatment of pediatric patients with major depressive disorder in their study it was found that this effect has not reached a statistical significance. Noteworthy the authors reported statistical significance for escitalopram when they only included adolescent subgroup into further analysis. However, there are also clinical trials in the literature reporting the effectiveness of escitalopram on adolescence major depressive disorder (Emslie, Findling). It was indicated that no serious adverse effect of escitalopram was reported in these studies comparing escitalopram with placebo. In this study the authors aimed to investigate the effect and reliability of the drug in the treatment of adolescents with major depressive disorder and/or anxiety disorders. Additionally, cognitive behavioral therapy and SSRIs are indicated for the first-line treatment of anxiety disorders. The authors included escitalopram for the treatment of pediatric anxiety disorders.

Official Title
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The Effect and Reliability of Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders

Conditions
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Major Depressive Disorder, Anxiety Disorders

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: drug-naive being in the age range of 12-18 lack of any psychiatric comorbidity, except for ADHD-like problems during the illness IQ level> 80 lack of history of any major medical disease, substance abuse Exclusion Criteria: inappropriate age history of drug abuse, major medical disease mental retardation any psychotropic drug use hospitalization required for suicidal ideation/behavior

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Adolescents with major depressive disorder or anxiety disorders will be recruited into 2 different diagnostic groups. Each group will include 30 participants. The total scores of the relevant assessment tools (Clinical Global Impression scale, Hamilton Rating Scale for Depression and Anxiety Disorders) at the starting point, 2nd and 6th month of the treatment will be compared.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Major depressive disorder<br>In this group, adolescents with major depressive disorder will be recruited. It was planned to include 30 participants.Escitalopram treatment will be given to those with Major Depressive Disorder with a starting dose of 2.5 mg day. The treatment dose will be gradually increased up to 20 mg day (if necessary) and the maximal treatment dose was determined as 30 mg day in each group. | Drug: Escitalopram<br>* Escitalopram treatment will be given to the arms with a starting dose of 2.5 mg day. The treatment dose will be gradually increased up to 20 mg day (if necessary) and the maximal treatment dose was determined as 30 mg day in each group.<br>* Other names: Lexapro;|
| Active Comparator: Anxiety disorders<br>In this group, adolescents with anxiety disorders will be recruited. It was planned to include 30 participants. Additionally, the specification of which anxiety disorders are assigned to the participants will also be provided. Escitalopram treatment will be given to participants with anxiety disorders with a starting dose of 2.5 mg day. The treatment dose will be gradually increased up to 20 mg day (if necessary) and the maximal treatment dose was determined as 30 mg day in each group. | Drug: Escitalopram<br>* Escitalopram treatment will be given to the arms with a starting dose of 2.5 mg day. The treatment dose will be gradually increased up to 20 mg day (if necessary) and the maximal treatment dose was determined as 30 mg day in each group.<br>* Other names: Lexapro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scale (CGI) | The authors will compare 3-time points of the treatment in the study. The first assessment point will be the starting point of the study and the other ones are 2nd and 6th months of the treatment course. Total scores of the CGI scale of the 3-time points will be recorded. Change in the scores of the starting point and 2nd month of the treatment will be compared. A decrease in the CGI score at the 2nd month of the treatment with a percentage of 50% or above will be considered as positive treatment response. The CGI score at the 6th month of the study with a result of 2 points or below will be accepted as remission. | will be assessed in the 1st, 2nd and 6th month of the treatment. | 
| The Hamilton Rating Scale for Depression | The authors will compare 3-time points of the treatment in the study. The first assessment point will be the starting point of the study and the other ones are 2nd and 6th months of the treatment course. Total scores of the Hamilton Depression scale of the 3-time points will be recorded. Change in the scores of the starting point and 2nd month of the treatment will be compared. A decrease in the Hamilton Depression scale score at the 2nd month of the treatment with a percentage of 50% or above will be considered as positive treatment response. Any scores on the Hamilton Depression scale below 8 points at the 6th month of treatment course will be accepted as remission. | will be assessed in the 1st, 2nd and 6th month of the treatment in major depressive disorder arm. | 
| The Hamilton Anxiety Rating Scale | The authors will compare 3-time points of the treatment in the study. The first assessment point will be the starting point of the study and the other ones are 2nd and 6th months of the treatment course. Total scores of the Hamilton Anxiety scale of the 3-time points will be recorded. Change in the scores of the starting point and 2nd month of the treatment will be compared. A decrease in the Hamilton Anxiety score at the 2nd month of the treatment with a percentage of 50% or above will be considered as positive treatment response. Any scores on the Hamilton Anxiety scale below 15 points at the 6th month of treatment course will be accepted as remission. | will be assessed in the 1st, 2nd and 6th month of the treatment in anxiety disorders arm. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major depressive disorder, anxiety disorders, adolescent, child