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Alpha-2 Adrenergic Agonist

Sertraline + Guanfacine for Depression (ACE-D Trial)

Phase 2

Waitlist Available

Led By Leanne Williams, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

At least moderately severe depression as defined as a score of 10 or higher on the PHQ-9

18-60 years of age

Must not have

Severe impediment to vision, hearing, and/or hand movement, likely to interfere with protocols

Current use of psychotropic medications contraindicated by GIR or the standard antidepressant medication, sertraline, to which subjects could be randomized

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see how a medication called guanfacine affects brain activity in people with depressive symptoms and cognitive issues."

Who is the study for?

This trial is for individuals experiencing symptoms of depression. Specific eligibility criteria are not provided, but typically participants must meet diagnostic criteria for the condition being studied and may need to pass certain health assessments to qualify.

What is being tested?

The study investigates how guanfacine, a psychotropic medication, affects brain network functioning in people with depressive symptoms. It also examines the interaction between this drug's effects on brain function and cognitive impairments associated with depression.

What are the potential side effects?

While specific side effects are not listed here, common side effects of sertraline can include nausea, dizziness, dry mouth, sleepiness or insomnia; guanfacine may cause drowsiness, low blood pressure, dry mouth and constipation.

Eligibility Criteria

Inclusion Criteria

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

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My depression is moderately severe or worse, based on a test score.

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I am between 18 and 60 years old.

Exclusion Criteria

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

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I have severe issues with my vision, hearing, or hand movement that could affect following treatment plans.

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I am not taking any psychotropic medications that are not allowed.

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I did not respond well to sertraline or guanfacine.

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I am currently taking medication that strongly affects liver enzyme levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Remission of depressive symptoms

Secondary study objectives

Change in disability

Change in quality of Life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sertraline + PlaceboExperimental Treatment1 Intervention

We will conduct a parallel-group, double-blind randomized trial at Stanford Bay Area and Chicago sites, identifying 160 participants with a prominent clinical cognitive signature (C+) and relative absence of the signature (C-). We will enrich for C+, the signature of interest, at a 2:1 ratio. Participants will be randomly assigned to receive guanfacine (shown to ameliorate cognitive control deficits in our preliminary data) plus sertraline or placebo plus sertraline.

Group II: Sertraline + GuanfacineExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sertraline

2002

Completed Phase 4

~5470

Guanfacine

2008

Completed Phase 4