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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

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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 below

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I have been experiencing pain for over 3 months.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 more

Awards & Highlights

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.

Trial 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.

0 / 3Eligibility criteria met