- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03122158
Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders
April 19, 2017 updated by: Muharrem Burak Baytunca, Erzurum Regional Training & Research Hospital
The Effect and Reliability of Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Palandöken
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Erzurum, Palandöken, Turkey, 25070
- ErzurumRTRH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Major depressive disorder
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.
|
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.
Other Names:
|
Active Comparator: Anxiety disorders
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression Scale (CGI)
Time Frame: will be assessed in the 1st, 2nd and 6th month of the treatment.
|
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
Time Frame: will be assessed in the 1st, 2nd and 6th month of the treatment in major depressive disorder arm.
|
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
Time Frame: will be assessed in the 1st, 2nd and 6th month of the treatment in anxiety disorders arm.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Muharrem Burak Baytunca, Erzurum Regional Training & Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wagner KD, Robb AS, Findling RL, Jin J, Gutierrez MM, Heydorn WE. A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents. Am J Psychiatry. 2004 Jun;161(6):1079-83. doi: 10.1176/appi.ajp.161.6.1079.
- Emslie GJ, Ventura D, Korotzer A, Tourkodimitris S. Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial. J Am Acad Child Adolesc Psychiatry. 2009 Jul;48(7):721-729. doi: 10.1097/CHI.0b013e3181a2b304.
- Findling RL, Robb A, Bose A. Escitalopram in the treatment of adolescent depression: a randomized, double-blind, placebo-controlled extension trial. J Child Adolesc Psychopharmacol. 2013 Sep;23(7):468-80. doi: 10.1089/cap.2012.0023.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 8, 2017
Primary Completion (Anticipated)
September 15, 2018
Study Completion (Anticipated)
December 15, 2018
Study Registration Dates
First Submitted
April 8, 2017
First Submitted That Met QC Criteria
April 19, 2017
First Posted (Actual)
April 20, 2017
Study Record Updates
Last Update Posted (Actual)
April 20, 2017
Last Update Submitted That Met QC Criteria
April 19, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Anxiety Disorders
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- ErzurumRTRH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
clinical severity of the participants measured by psychiatric tools and mean drug dose will be shared during the course of the study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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