sertraline for Anxiety Disorders

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Anxiety Disorderssertraline - Drug
Eligibility
8 - 17
All Sexes
What conditions do you have?
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Study Summary

This trial tested whether the drug sertraline is effective in treating acute depression.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Week 12

Week 12
Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Sertraline
5%tiredness/ sleepiness
This histogram enumerates side effects from a completed 2009 Phase 4 trial (NCT00159965) in the Sertraline ARM group. Side effects include: tiredness/ sleepiness with 5%.

Trial Design

3 Treatment Groups

Healthy Control
1 of 3
sertraline
1 of 3
Placebo
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

150 Total Participants · 3 Treatment Groups

Primary Treatment: sertraline · Has Placebo Group · Phase 4

sertraline
Drug
Experimental Group · 1 Intervention: sertraline · Intervention Types: Drug
Healthy ControlNoIntervention Group · 1 Intervention: Healthy Control · Intervention Types:
Placebo
Drug
PlaceboComparator Group · 1 Intervention: sertraline · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sertraline
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 12

Who is running the clinical trial?

University of CincinnatiLead Sponsor
387 Previous Clinical Trials
635,445 Total Patients Enrolled
6 Trials studying Anxiety Disorders
945 Patients Enrolled for Anxiety Disorders
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,821 Previous Clinical Trials
2,237,986 Total Patients Enrolled
3 Trials studying Anxiety Disorders
315 Patients Enrolled for Anxiety Disorders
Jeffrey R Strawn, MD, FAACAPPrincipal InvestigatorUniversity of Cincinnati

Eligibility Criteria

Age 8 - 17 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients, parent/guardian/LAR must be fluent in the English.
You must practice a reliable method of contraception for the duration of the study and within 30 days following the end of study participation.
A reliable method of contraception is defined below.
You are willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, and oversee the administration of the investigational product.