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Selective Serotonin Reuptake Inhibitor

Escitalopram for Bipolar Disorder

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

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

Bipolar Disorder
Depression
Anxiety

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between week 4 and 16

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

Tension/Inner Unrest

Reduced Salivation

Concentration Difficulties

Diminished Sexual Drive

Asthenia/Lassitude/Increased Fatigability

Constipation

Polyuria/Polydipsia

Orthostatic Dizziness

Nausea/Vomiting

Erectile Dysfunction

Failing Memory

Diarrhea

Increased Duration of Sleep

Reduced Duration of Sleep

Increased Dream Activity

Accomodation Disturbance

Increased Tendancy to Sweating

Weight Gain

Ejaculatory Dysfunction

Micturtion Disturbances

100%

80%

60%

40%

20%

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

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