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Alpha-2 Adrenergic Agonist

Guanfacine for Depression (BIG Trial)

Phase 4
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-65 years of age (inclusive)
Medication naïve to guanfacine
Must not have
Current use of a strong CYP3A4 inhibitor or inducer
Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments, or are unable and/or unlikely to follow the study protocols
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks, 6 weeks
Awards & highlights

Summary

This trial is testing whether the drug guanfacine can help people with major depression that arises from dysfunction in cognitive control neural circuitry.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Guanfacine may cause side effects such as drowsiness, low blood pressure, slow heart rate and possibly fainting. It might also interact with other medications affecting liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have never taken guanfacine before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication that strongly affects liver enzyme levels.
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I have severe issues with vision, hearing, or hand movement that could prevent me from following study instructions.
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I have never been diagnosed with bipolar disorder, eating disorders, ADHD, schizophrenia, or psychosis.
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I have been diagnosed with PTSD or OCD according to DSM-5.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks, 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks, 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in dorsolateral prefrontal cortex (DLPFC) activity
Secondary outcome measures
Change in digit span task performance
Change in maze task performance
Change in verbal memory recognition task performance
Other outcome measures
Change in Barratt Impulsiveness Scale (BIS) score
Change in Beck Anxiety Inventory (BAI)
Change in Beck Depression Inventory (BDI)
+19 more

Side effects data

From 2014 Phase 4 trial • 62 Patients • NCT01238575
87%
Drowsiness
63%
Fatigue
43%
Decreased Appetite
40%
Emotional/tearful
40%
Dry Mouth
37%
Irritability
30%
Anxiety
30%
Increased Energy
30%
Mid sleep awakening
30%
Headache
27%
Stomachache
23%
Constipation
17%
Aggression
17%
Increased Repetitive Behavior
13%
Depressed Mood
13%
Cough/Congestion
10%
Diarrhea
10%
Silly
10%
Weakness
10%
Vomiting
10%
Self-injury
10%
Nausea
10%
Trouble Falling Asleep
10%
Dizziness
7%
Blurred Vision
7%
Skin rash/Eczema
7%
Nightmares
7%
Enuresis
7%
Increased Appetite
7%
Excessive Talking
3%
Aggressive
3%
Fever
3%
Motor Tics
3%
Skin Picking
100%
80%
60%
40%
20%
0%
Study treatment Arm
Extended-release Guanfacine
Inactive Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Guanfacine Treatment GroupExperimental Treatment1 Intervention
Participants will be prescribed tabs containing guanfacine immediate release (GIR) to be taken for 4 weeks and will be monitored by one of the study psychiatrists. Subjects randomized to GIR will start with 0.25mg GIR upon waking and increase by 0.25mg every other day with a goal dose of 2mg.
Group II: Placebo GroupPlacebo Group1 Intervention
Participants will be prescribed tabs containing placebo to be taken for 4 weeks and will be monitored by one of thestudy psychiatrists. Subjects randomized placebo will be asked to follow the same pill regimen as subjects randomized to treatment.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression include Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), which work by increasing the levels of serotonin and norepinephrine in the brain, respectively. These neurotransmitters are crucial for mood regulation. Guanfacine, an Alpha-2A Adrenergic Receptor Agonist, targets a different mechanism by modulating the adrenergic system, which can influence cognitive control and emotional regulation. Understanding these mechanisms is vital for patients as it helps tailor treatments to their specific neurochemical imbalances, potentially improving efficacy and reducing side effects.
How to improve the risk-benefit ratio of antidepressants.Strategies to achieve clinical effectiveness: refining existing therapies and pursuing emerging targets.Bulimia nervosa : a review of therapy research.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,411 Previous Clinical Trials
17,462,875 Total Patients Enrolled
109 Trials studying Depression
94,132 Patients Enrolled for Depression

Media Library

Guanfacine Pill (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04181736 — Phase 4
Depression Research Study Groups: Placebo Group, Guanfacine Treatment Group
Depression Clinical Trial 2023: Guanfacine Pill Highlights & Side Effects. Trial Name: NCT04181736 — Phase 4
Guanfacine Pill (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04181736 — Phase 4
~11 spots leftby Dec 2024