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Anti-convulsants
Anti-depressants vs Anti-convulsants for Chronic Pain (SPEC-AA 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
Persistent pain for more than 3 months
Age of 18 years old or above
Must not have
Patient refusal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
This trial aims to study whether or not anti-convulsants or anti-depressants are more effective for treating chronic pain, as well as to build a model to help predict which medication may work better for individual patients based on clinical characteristics.
Who is the study for?
This trial is for adults over 18 with chronic pain lasting more than 3 months, who could be treated with anti-convulsants or anti-depressants. Patients must have a balanced chance of benefiting from either medication as judged by their doctor. Those with conditions that prevent the use of these drugs or who refuse to participate are excluded.
What is being tested?
The study compares the effectiveness of two common chronic pain treatments: anti-convulsant and anti-depressant medications. It involves randomly assigning patients to one treatment group during clinic visits using an open-source system called CHOIR, which tracks patient outcomes.
What are the potential side effects?
Potential side effects from the medications may include dizziness, drowsiness, nausea, weight changes, mood swings, and possible drug interactions. The specific side effects can vary based on individual health conditions and the type of medication prescribed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been experiencing pain for over 3 months.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have chosen not to participate in certain treatments or procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Pain Intensity
Secondary study objectives
Change in Anxiety
Change in Depression
Change in Pain Catastrophizing
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Anti-depressant medicationExperimental Treatment1 Intervention
The participants will be randomized to receiving an anti-depressant medication. Then using a patient centered approach, the participant and their treating pain provider will choose one medication within the class. Participants will continue the medications for at least 6 months provided that they can tolerate the side effects, consider the treatment effective, and are willing to continue the treatment. We are studying two classes of medications and specific names of medications do not apply.
Group II: Anti-convulsant medicationExperimental Treatment1 Intervention
The participants will be randomized to receiving an anti-convulsant medication. Then using a patient centered approach, the participant and their treating pain provider will choose one medication within the class. Participants will continue the medications for at least 6 months provided that they can tolerate the side effects, consider the treatment effective, and are willing to continue the treatment. We are studying two classes of medications and specific names of medications do not apply.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,491,944 Total Patients Enrolled
38 Trials studying Chronic Pain
8,898 Patients Enrolled for Chronic Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chosen not to participate in certain treatments or procedures.I cannot take anti-convulsants or anti-depressants as advised by my doctor.The treating pain provider is unsure about the best choice between anti-convulsants and anti-depressants for your condition.I have been experiencing pain for over 3 months.My doctor recommends anti-convulsants or anti-depressants for my pain.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Anti-convulsant medication
- Group 2: Anti-depressant medication
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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