ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression

Conditions

• Depression

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Guanfacine — DRUG
  Guanfacine immediate release is an established and safe FDA-approved treatment that acts directly by stimulating α2A adrenoceptors.
• Sertraline — DRUG
  Sertraline is a well-tolerated FDA-approved antidepressant that is among the most widely prescribed medications for depression.

Study Details

The purpose of this study is to understand how a psychotropic medication called guanfacine affects brain network functioning in humans, and how this function interacts with cognitive impairments in people experiencing depressive symptoms.

Key Dates

Start date

Mar 3, 2026

Status verified

Mar 2026

Primary completion

Oct 1, 2028

Completion

Feb 1, 2029

Study Design

Enrollment

162 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sertraline + Guanfacine
  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.
• Experimental: Sertraline + Placebo
  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.

Primary Outcome Measure

Remission of depressive symptoms [ Time Frame: 8 weeks ]

Central Contacts

• Leyla Boyar, BA
  6504989326
  [email protected]
• Isabelle Wydler Clinical Research Coordinator, BA
  6507364393
  [email protected]

Locations (2)

Find similar trials in Palo Alto, CA

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