Guanfacine for Depression

(BIG Trial)

Overseen by Leanne M Williams, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests guanfacine, a drug commonly used for ADHD and high blood pressure, to see if it can help adults with certain types of depression. The study focuses on people whose depression might be due to problems in brain areas that control thinking and decision-making. Guanfacine aims to improve these brain functions, potentially offering a new treatment option for this group.

Research Team

Laura M Hack, MD, PhD

Principal Investigator

Stanford University

Leanne M Williams, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults aged 18-65 with major depression, who perform poorly on certain memory tasks and have specific brain activity patterns. They must not be pregnant, using psychotropic drugs without a washout period, or have metal in their body that affects MRI scans. People with recent substance abuse, PTSD, OCD, severe mental disorders like bipolar or schizophrenia are excluded.

Inclusion Criteria

Fluent and literate in English, and show non-impaired intellectual abilities to ensure adequate comprehension of the task instructions

Score > 14 on the Hamilton Depression Rating Scale 17

Meet DSM-5 diagnostic criteria for current, past, or recurrent nonpsychotic major depressive disorder established by MINI Plus

Exclusion Criteria

I have no history of illnesses or injuries that affect my thinking or memory.

I am currently taking medication for mental health, but can stop if needed.

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

Treatment Details

Interventions

• Guanfacine Pill (Alpha-2 Adrenergic Agonist)
• Placebo (Drug)

Trial Overview The study tests guanfacine's effect on a type of major depression linked to cognitive control issues. Participants will either receive guanfacine or a placebo. Their brain function is monitored via fMRI to see if the drug improves symptoms compared to no active treatment.

Participant Groups

Group I: Guanfacine Treatment Group Experimental Treatment 1 Intervention

Participants will be prescribed tabs containing guanfacine immediate release (GIR) to be taken for 8 weeks and will be monitored by one of the study psychiatrists/nurse practitioners. Subjects will start with 0.5mg GIR nightly and increase by 0.5mg every 3 days with a goal dose of 2mg.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD