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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 is testing whether the antidepressant escitalopram is effective in treating adolescents with depression and/or anxiety who have a family history of bipolar disorder.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amygdaloid structure
Secondary outcome measures
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
431 Previous Clinical Trials
634,332 Total Patients Enrolled
21 Trials studying Depression
1,197 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,605 Total Patients Enrolled
675 Trials studying Depression
256,675 Patients Enrolled for Depression
Melissa P DelBello, MD, MSPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
1,565 Total Patients Enrolled
~22 spots leftby Jul 2025