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

NCT ID: NCT03122158

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-08
• Study Completion Date: 2018-12-15

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.

Conditions

Major Depressive Disorder; Anxiety Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Lexapro

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erzurum Regional Training & Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muharrem Burak Baytunca

Child Psychiatry Consultant, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muharrem Burak Baytunca

Role: PRINCIPAL_INVESTIGATOR

Erzurum Regional Training & Research Hospital

Locations

ErzurumRTRH

Erzurum, Palandöken, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 15169696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19465881 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24041408 (View on PubMed)

Other Identifiers

ErzurumRTRH

Identifier Type: -

Identifier Source: org_study_id