Early Psychiatric Intervention After Orthopaedic Trauma: A Prospective, Randomized Double-Blinded Placebo Controlled Trial

Study ID
STU 092010-179

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Cynthia Wright
214-645-3367
cynthia.wright@utsouthwestern.edu

Principal Investigator
Adam Starr

Summary

up to 230 patients will receive either paroxetine or a placebo disoensed by Pharmacy according to the randomization schedule, to provide a double-blind treatment schedule. at each clinic visit, the patient will be evaluated bythe treating clinician for medication adherence, tolerability, side effects, and clinical assessment of emotionl state, along with orthopaedic staus. the starting dose of paroxetine will be 20 mg per day (10 mg per day in patients [Greater Than] 65 years of age, patients with compromised kidney or liver function, and in patients taking medications that inhibit paroxetine metabolism). at any subsequent appointment, the medication (either paroxetine or placebo) is being well tolerated and insufficient psychiatric improvement has been made, the dose will be doubled to 40 mg per day (or 20 mg per day in elderly patients, those with renal/hepatic compromise, or patients taking medications that inhibit paroxetine metabolism) for paroxetine and to a [Quote]double[Quote] dose of placebo.Should bothersome side effects occur, the medicationdose will be reduced by one-half. The treating clinitian will decide, after clinical examination of the patient, whether a dosage increase or decrease is indicated.

medication will be given for 6 months after trauma, and the discontinued. at baseline (time of enrollment) and at each subsequent clinic visit, patients will complete self-administered questionnaires of post-traumatic symptoms (PTSD check list PCL) and depressive symptoms (Beck Depression inventory, BDi) additionally at each subsequent clinic visit, patients will complete checklist of medication side effects and medication adherence. at the final appointment, patients will also be assessedfor PTSD and major depression using the relevant modules of a structured diagnostic instrument, the Diagnostic interview Schedule for DSM-iV (DiS-iV), at that time, patients diagnosed with PTSD or major depression that has not been remitted during the study will be offered referal for the appropriate psychiatric care. Functional outcomes following the traumatic orthopaedic injury will be assesed at each visit following the first clinic appointment. The assessment of outcome will be done using the SF-36 and the Short Musculoskeletal Functional assessment (SMFa). Patients will be scheduled for clinic appointments at 2 weeks, 4 weeks, 6 weeks, 12 weeks, 6 months, and 12 months post injury. if clinically indicated or by patient request, additional appointments can be scheduled. at each appointment, the patient's orthopaedic and mental status will be assessed by the treating clinician as well as clinical mentoring of medication use and tolerability and clinical mental health status. at the final appointment, the treating clinician will provide patient education reguarding treatment alternatives for continued therapy.

Study patients will be paid a total of $200 for their participation in the research project. The funds will be distributed as follows: 2 week follow up $40; 4 week follow up $30, 6 week follow up $30, 12 week follow up $30, 6 month follow up $30, 12 month follow up $40

This money will be offered in order to improve enrollment, facilitate retention, and to compensate the patients for their time spent completing study-related questionnaires.

Participant Eligibility


* Patients admitted to our trauma center for an orthopedic injury with Injury Severity Score >8.

* Patient must sign and date the IRB approved informed consent form