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Selective Serotonin Reuptake Inhibitor

Escitalopram for Depression

N/A
Waitlist Available
Led By Melissa P DelBello, MD, MS
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between week 4 and 16
Awards & highlights

Summary

This trial investigates the use of escitalopram in adolescents with depression or anxiety who have a family history of Bipolar Disorder. The study aims to understand how the medication affects these high-risk youths and identify any potential side effects. Escitalopram helps balance brain chemicals to improve mood but may cause unwanted side effects.

Eligible Conditions
  • Depression
  • Bipolar Disorder
  • Anxiety

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between week 4 and 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and between week 4 and 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amygdaloid structure
Secondary study objectives
Mood (psychological function)

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004
23%
Sleepiness/Sedation
10%
Headache
8%
Tension/Inner Unrest
8%
Reduced Salivation
8%
Concentration Difficulties
8%
Diminished Sexual Drive
6%
Asthenia/Lassitude/Increased Fatigability
6%
Constipation
6%
Polyuria/Polydipsia
6%
Orthostatic Dizziness
4%
Nausea/Vomiting
4%
Erectile Dysfunction
4%
Failing Memory
2%
Diarrhea
2%
Increased Duration of Sleep
2%
Reduced Duration of Sleep
2%
Increased Dream Activity
2%
Accomodation Disturbance
2%
Increased Tendancy to Sweating
2%
Weight Gain
2%
Ejaculatory Dysfunction
2%
Micturtion Disturbances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Escitalopram and Placebo
Escitalopram and Memantine

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: MED - Escitalopram with psychotherapyExperimental Treatment1 Intervention
Youth will also be assigned a board certified child psychiatrist (Drs. Singh or Chang at Stanford; Drs. DelBello or Patino at UC), who will be blind to treatment condition and see youth weekly for the first 4 weeks, then biweekly until 16 weeks. Youth in the MED condition will be given the USFDA (US Food \& Drug Administration) approved antidepressant, escitalopram for the treatment of depression or anxiety in youth and follow a standard dose titration schedule of 5 mg/day for 1 week, 10mg/day for 1 week, then with a target dose of 20-30 mg/day by 4 weeks.
Group II: Healthy ControlActive Control1 Intervention
60 (30 at Stanford, 30 at University of Cincinnati) 12- to 17-year old male and female typically developing healthy controls. Healthy controls will receive behavioral, neural, and physiological assessments at baseline only. healthy controls will be scanned at baseline only and serve as a reference group to determine whether MRI changes observed in the high-risk group from baseline to week 4 are toward or away from normal.
Group III: No MED -PsychotherapyPlacebo Group1 Intervention
All participants (No MED and MED) will be assigned a study-trained therapist who will provide hour-long weekly individual cognitive behavioral psychotherapy (CBT) based on current evidence-based practices for the treatment of anxiety and depressive symptoms for youth.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram
2005
Completed Phase 4
~2330

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
433 Previous Clinical Trials
636,189 Total Patients Enrolled
22 Trials studying Depression
3,132 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,322 Total Patients Enrolled
687 Trials studying Depression
258,071 Patients Enrolled for Depression
Melissa P DelBello, MD, MSPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
1,565 Total Patients Enrolled
~22 spots leftby Sep 2025
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