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 : 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

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Anxiety Disorders Drug: Escitalopram Phase 4

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  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: The Effect and Reliability of Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders
Actual Study Start Date : April 8, 2017
Estimated Primary Completion Date : September 15, 2018
Estimated Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.
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

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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122158


Locations
Turkey
ErzurumRTRH
Erzurum, Palandöken, Turkey, 25070
Sponsors and Collaborators
Erzurum Regional Training & Research Hospital
Investigators
Principal Investigator: Muharrem Burak Baytunca Erzurum Regional Training & Research Hospital

Publications:
Responsible Party: Muharrem Burak Baytunca, Child Psychiatry Consultant, MD, Erzurum Regional Training & Research Hospital
ClinicalTrials.gov Identifier: NCT03122158     History of Changes
Other Study ID Numbers: ErzurumRTRH
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
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

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

Keywords provided by Muharrem Burak Baytunca, Erzurum Regional Training & Research Hospital:
major depressive disorder
anxiety disorders
adolescent
child

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Mood Disorders
Behavioral Symptoms
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents