8 Participants Needed

Nortriptyline for Concussion

(PeCon Trial)

Age: < 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Lancaster General Hospital
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests whether nortriptyline can help people with headaches after a concussion. Participants will receive nortriptyline along with standard headache treatments. The goal is to see if nortriptyline reduces headache symptoms faster by balancing brain chemicals. Nortriptyline has been tested previously for migraine prevention, but it was not effective when used alone.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any medication for concussion other than NSAIDs or acetaminophen.

Is the drug nortriptyline effective for treating symptoms after a concussion?

Research shows that nortriptyline, a type of antidepressant, has been helpful for some people with conditions like tinnitus and depression, which suggests it might also help with concussion symptoms. However, its effectiveness specifically for concussion needs more direct study.12345

Is nortriptyline generally safe for humans?

Nortriptyline has been studied in both adolescents and elderly people for depression, and while it did not show significant anticholinergic side effects (like dry mouth or blurred vision) in adolescents, it did affect memory performance in elderly individuals. A study on children and adolescents also looked at heart-related effects, but specific safety outcomes were not detailed in the provided abstracts.56789

How does the drug nortriptyline differ from other treatments for concussion?

Nortriptyline is unique for concussion treatment as it is primarily a tricyclic antidepressant, typically used for depression and other conditions like tinnitus and Parkinson's disease-related depression. Its use in concussion is novel, as there are no standard treatments specifically targeting concussion symptoms with this mechanism of action.2561011

Research Team

PM

Patrick Moreno, MD

Principal Investigator

Lancaster General Health Sports Medicine

LD

Laura DiPaolo, MD

Principal Investigator

Lancaster General Health Sports Medicine

Eligibility Criteria

This trial is for young people aged 13-21 who've had a concussion with headaches lasting over 4 weeks. They must be in good health, able to take pills, and not on other concussion meds except common painkillers. Those with severe brain injuries, uncontrolled mental illness, pregnancy, or known allergies to the drug can't join.

Inclusion Criteria

I am only taking NSAIDs or acetaminophen for my concussion.
It has been over 4 weeks since my concussion.
My headache, head pressure, and neck pain score is over 3.
See 7 more

Exclusion Criteria

You have any recent abnormal findings on a CT scan.
I have a history of Brugada syndrome.
I have specific nerve or brain function issues after an injury.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either nortriptyline or placebo daily for 4 weeks, along with standard headache treatment

4 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Nortriptyline
  • Placebo
Trial OverviewThe study tests if Nortriptyline helps reduce headache symptoms faster than a placebo when added to standard treatments. Participants are randomly assigned to either the drug or placebo group and monitored weekly for symptom changes over four weeks.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
10mg capsule once daily for 4 weeks of nortriptyline
Group II: ControlPlacebo Group1 Intervention
10mg capsule once daily for 4 weeks of Thick-It filler

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lancaster General Hospital

Lead Sponsor

Trials
25
Recruited
4,100+

References

Gabapentin and Tricyclics in the Treatment of Post-Concussive Headache, a Retrospective Cohort Study. [2020]
Antidepressant treatment of tinnitus patients: report of a randomized clinical trial and clinical prediction of benefit. [2022]
Nortriptyline versus fluoxetine in the treatment of depression and in short-term recovery after stroke: a placebo-controlled, double-blind study. [2022]
Use of Amitriptyline in the Treatment of Headache After Traumatic Brain Injury: Lessons Learned From a Clinical Trial. [2021]
Effects of nortriptyline on memory self-assessment and performance in recovered elderly depressives. [2013]
Double-blind placebo-controlled study of nortriptyline in depressed adolescents using a "fixed plasma level" design. [2013]
A retrospective study of serum levels and electrocardiographic effects of nortriptyline in children and adolescents. [2013]
Baseline and 2- to 3-year follow-up characteristics of placebo-washout responders from the nortriptyline study of depressed 6- to 12-year-olds. [2013]
An investigation of the effects of lofepramine, nomifensine, amitriptyline and placebo on aspects of memory and psychomotor performance related to car driving. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
10-Hydroxynortriptyline and treatment effects in elderly depressed patients. [2013]
Anti-depressive treatment in Parkinson's disease. A controlled trial of the effect of nortriptyline in patients with Parkinson's disease treated with L-DOPA. [2022]