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

NCT03122158 | Unknown Phase 4

• 1 other identifier: ErzurumRTRH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder; Anxiety Disorders

Keywords

major depressive disorder; anxiety disorders; adolescent; child

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Major depressive disorder

ACTIVE COMPARATOR

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

Anxiety disorders

ACTIVE COMPARATOR

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

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro

Anxiety disorders; Major depressive disorder

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• inappropriate age
• history of drug abuse, major medical disease
• mental retardation
• any psychotropic drug use
• hospitalization required for suicidal ideation/behavior

Sponsors & Collaborators

• Erzurum Regional Training & Research Hospital: lead

Study Sites (1)

ErzurumRTRH

Erzurum, Palandöken, 25070, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 15169696 BACKGROUND

• 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.

  PMID: 19465881 BACKGROUND

• 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.

  PMID: 24041408 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders

Interventions

Escitalopram

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

Study Officials

• Muharrem Burak Baytunca

  Erzurum Regional Training & Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Child Psychiatry Consultant, MD

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2017
• First Posted: April 20, 2017
• Study Start: April 8, 2017
• Primary Completion: September 15, 2018
• Study Completion: December 15, 2018
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)