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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks, 6 weeks
Awards & highlights
BIG Trial 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.
BIG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I have never taken guanfacine before.
BIG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks, 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks, 6 weeks
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 moreSide effects data
From 2014 Phase 4 trial • 62 Patients • NCT0123857587%
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
BIG 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.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,172 Total Patients Enrolled
107 Trials studying Depression
93,884 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have severe issues with vision, hearing, or hand movement that could prevent me from following study instructions.I have never been diagnosed with bipolar disorder, eating disorders, ADHD, schizophrenia, or psychosis.You have thoughts of hurting yourself, which is determined by a high score on a mental health assessment or by the judgment of a healthcare provider.You have been diagnosed with an alcohol or drug problem in the past year.I do not have any major health issues that could make treatment unsafe for me.I am between 18 and 65 years old.I have been diagnosed with PTSD or OCD according to DSM-5.I have never taken guanfacine before.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Group
- Group 2: Guanfacine Treatment Group
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings available for this clinical experiment?
"Affirmative. According to the clinicaltrials.gov database, recruitment for this medical trial is ongoing since July 1st 2022 and recently updated on December 1st 2022. 64 people are needed from a single site for potential enrolment into the study."
Answered by AI
Does this trial encompass individuals aged sixty and over?
"This medical experiment is inviting individuals aged 18 or older, but under 65 years old."
Answered by AI
Could you summarize the foregoing research related to Guanfacine Pill?
"Currently, there are 9 studies exploring Guanfacine Pill. Of these, two have progressed to the third stage of clinical trials. While most testing is conducted in Palo Alto, California; 80 other sites across the United States are also running this experiment."
Answered by AI
What is the scope of recruitment for this research endeavor?
"Affirmative. The information on clinicaltrials.gov shows that this medical trial is actively seeking patients, and was first published on July 1st 2022 with the most recent update posted December 1st 2022. A total of 64 people are required to take part in the study at a single facility."
Answered by AI
Are there any potential risks associated with taking Guanfacine Pill?
"The safety of guanfacine pill was judged to be a 3, since Phase 4 clinical trials are conducted after the drug has been approved."
Answered by AI
Am I eligible to become a participant in this medical experiment?
"Patients with an age between 18 and 65, diagnosed with psychosis, must apply for the clinical trial. The researchers are aiming to recruit a total of 64 individuals."
Answered by AI
Is this test protocol unprecedented in its scope?
"Presently, there are 9 running clinical trials for Guanfacine Pill in 24 cities and 9 countries. This drug was initially tested in 2018 by Shire with 20 participants; since then, 18357 studies have been conducted and the medication has now progressed to its N/A approval stage."
Answered by AI
Who else is applying?
What site did they apply to?
Stanford Psychiatry
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Have tried multiple meds + TMS + Ketamine.
PatientReceived 1 prior treatment
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