A Randomized Clinical Trial of Quetiapine to Reduce Post Concussive Syndrome Polypharmacy

NCT06333990 Phase 3 RECRUITING

A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD).

Details

Lead sponsor	Foundation for Advancing Veterans' Health Research
Phase	Phase 3
Status	RECRUITING
Enrolment	146
Start date	2024-07-09
Completion	2028-06

Conditions

• Mild Traumatic Brain Injury

Interventions

• Quetiapine Fumarate
• TAU

Primary outcomes

• Neurobehavioral Symptom Inventory — 2 weeks
  A 22- item, self-report measure of symptoms of postconcussive symptoms severity for the preceding 2 week period. Items are scored on a 5-point scale, and a total score is obtained by summing the 22 symptom items, with higher scores indicate greater symptom severity. The total scores range from 0 - 88.
• World Health Organization Disability Assessment Scale — 30 days
  A 12-item, self-report measure of functional disability for the preceding 30 days. Items are scored on a 5-point scale, and a total score is obtained by summing the 12 activities, with higher scores indicate greater disability. The total scores range from 0 - 48.
• World Health Organization Quality of Life BREF — 2 weeks
  A 26- item, self-report measure to assess functioning and quality of life for the preceding 2 week period. It is a measure of conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, independence, and recreation.

Countries

United States