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Selective Serotonin Reuptake Inhibitor

Sertraline for PTSD (SSRI Trial)

Phase 4

Recruiting

Led By Suzanne Pineles, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets diagnostic criteria for PTSD, subthreshold PTSD, or MDD as defined by DSM-5

Be older than 18 years old

Must not have

Evidence of clinically significant hepatic or renal disease or any other acute or unstable medical condition that might interfere with safe conduct of the study

Major neurological problems

Timeline

Screening 3 weeks

Treatment Varies

Follow Up administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing a brief screening to see if it can predict which people with PTSD or depression will respond well to SSRI medications. 94 people are needed for the 17 week study.

Who is the study for?

This trial is for veterans with PTSD or major depression who've experienced trauma, meet DSM-5 criteria for these conditions, and are open to trying SSRI medication. They shouldn't have a severe substance use disorder, be at immediate risk of harm to self or others, have used certain serotonin-affecting drugs recently, be pregnant, or currently in specific psychotherapies.

What is being tested?

The study tests if a brief screening can predict positive responses to SSRIs in those with PTSD or depression. Participants will either receive the SSRI sertraline or a placebo over 17 weeks to assess the effectiveness of this prediction method.

What are the potential side effects?

Sertraline may cause side effects like nausea, sleep issues, tremors, dizziness, dry mouth, loss of appetite and sexual side effects. Placebos typically don't cause side effects but any symptoms reported by participants receiving it will be noted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PTSD, subthreshold PTSD, or major depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe liver, kidney, or other unstable health conditions.

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I have significant issues with my nervous system.

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I have a history of bipolar I, schizophrenia, or another psychotic disorder.

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I have tried sertraline before and it didn't work for me.

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I do not have a severe brain injury or any condition faking illness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change

Secondary study objectives

Depression Anxiety Stress Scales (DASS-21) Change

Hamilton Depression Rating Scale (HAM-D) Change

PTSD Checklist for DSM-5 (PCL-5) Change

+3 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Sertraline armActive Control3 Interventions

After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.

Group II: Placebo only armPlacebo Group2 Interventions

For individuals who are placebo responders during the 2 week placebo lead in phase, they will remain on placebo for the duration of the study (i.e., the 12 weeks where the placebo non-responders are taking sertraline).

0 / 6Eligibility criteria met