Clinical trial NCT03122158: Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders
Official title: The Effect and Reliability of Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Anxiety Disorders
Keywords: major depressive disorder
anxiety disorders
adolescent
child
Lead sponsor: Erzurum Regional Training & Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Clinical Global Impression Scale (CGI)
timeFrame: will be assessed in the 1st, 2nd and 6th month of the treatment.
measure: The Hamilton Rating Scale for Depression
timeFrame: will be assessed in the 1st, 2nd and 6th month of the treatment in major depressive disorder arm.
measure: The Hamilton Anxiety Rating Scale
timeFrame: will be assessed in the 1st, 2nd and 6th month of the treatment in anxiety disorders arm.
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: ErzurumRTRH
state: Palandöken
Study officials:
affiliation: Erzurum Regional Training & Research Hospital
name: Muharrem Burak Baytunca
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.