Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03122158
Recruitment Status : Unknown
Verified April 2017 by Muharrem Burak Baytunca, Erzurum Regional Training & Research Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Muharrem Burak Baytunca, Erzurum Regional Training & Research Hospital

Tracking Information
First Submitted Date  ICMJE April 8, 2017
First Posted Date  ICMJE April 20, 2017
Last Update Posted Date April 20, 2017
Actual Study Start Date  ICMJE April 8, 2017
Estimated Primary Completion Date September 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders
Official Title  ICMJE The Effect and Reliability of Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Anxiety Disorders
Intervention  ICMJE Drug: Escitalopram
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 Name: Lexapro
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Escitalopram
  • 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.
    Intervention: Drug: Escitalopram
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 19, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2018
Estimated Primary Completion Date September 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03122158
Other Study ID Numbers  ICMJE ErzurumRTRH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: clinical severity of the participants measured by psychiatric tools and mean drug dose will be shared during the course of the study
Responsible Party Muharrem Burak Baytunca, Erzurum Regional Training & Research Hospital
Study Sponsor  ICMJE Erzurum Regional Training & Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Muharrem Burak Baytunca Erzurum Regional Training & Research Hospital
PRS Account Erzurum Regional Training & Research Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP