Clinical Trial copy
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Medicine
Date
Apr 3, 2024
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Uploaded by DrThunderAlligator6
1) Name the study and provide a link.
Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD
https://clinicaltrials.gov/ct2/show/NCT02382848?cond=%22Bulimia+Nervosa
%22&draw=8&rank=67
https://clinicaltrials.gov/ProvidedDocs/48/NCT02382848/Prot_SAP_000.pdf
2) Describe the aims of the study.
The aim of the study is to identify the effectiveness of Prazosin when treating Bulimic patients who experience distressing nightmares. This is done using subjective and objective measures. This will help to improve future clinical care. The investigators will be identifying the effects of Prazosin on bulimia and decreasing nightmare, specifically through subjective scales. They will also try to identify the effects on sleep using objective polysomnogram (PSG) measurements. This will help to educate them on psychopharamacologic and psychotherapeutic tactics to improve clinical care. 3)
Is the study a clinical trial (aka an interventional study) or an observational study? (Both kinds of study are listed at ClinicalTrials.gov.) If a clinical trial, what are its research plan and what is its protocol?
The study is Interventional (Clinical Trial). The investigators will be testing 10 participants. * of them will be tested using subjective measures (PHASE A). The 2 other participants will be tested
using objective PSG measurements, but only if there is a signal of efficacy detected within the 8 participants(PHASE B). 4) Who is the study’s lead investigator? Who makes up their team (even if names aren’t given, it should be listed whether they are doctors, social workers, scientists, etc)?
The study’s lead investigator is Fauzia Mayr form Penn State College of Medicine. 5) Who is sponsoring or funding the study?
The sponsor of this study os Milton S Hershey Medical Center located on Hershey, Pennsylvania. 6) What is the study’s recruitment status? Has the study been evaluated by the US federal government?
The recruitment status is complete. The recruitment process involves obtaining the consent and avoid coercion from the healthcare provider. The verbal consent is required through the phone at the scheduled time the patient chose for therapist evaluation, screening lab work, pregnancy test, saliva collection, BMI , and Vital signs. The study has yet to be evaluated by the. Federal government
7)
Describe the procedures of the study.
PHASE A: Some subjective scales that will be addressed are Eating Pathology, PTSD checklist, Clinician PTSD scale, Pittsburg sleep quality index, Hamilton Depression rating scale, and a sleep questionnaire. Additionally, there will be a collection of Salivary Cortisol, BMI, Vital Signs, LFT, UDS, and CMP.
If the patients fall into the eligibility criteria for the EKG and labs they will then be assessed by a
psychiatrist. Diurnal salivary samples will be obtained, as well. The participants will be randomly selected to take one of the treatments (Prazosin and Placebo). A rating scale will also be collected the first day and last day of the first treatment, as well as, second. Vital signs will be
checked at every physician appointment. 1 mg of prazosin will be prescribed on the second day of the study. Every 7 days, based on how severe the nightmares are and clinical response, the medication may be adjusted by 1-2 mg. The side effects scale will be used weekly to monitor any
symptoms. The maximum dosage of Prazosin will be 6 mg daily. The questionnaires will be used
to assess the nightmares. The participants are also entitled to 7 psychiatric visits. Additionally, blood tests, diurnal salivary samples, cortisol levels will be administered and collected. 2 new participants will take part in this phase and the procedures will be the same as PHASE A
PHASE B: The objective measures that will be taken includes a PSG. This will occur 3 consecutive nights at the start and the last 3 nights of the treatment. Therefore, each participant will have a PSG administered 9 nights. 2 new participants will take part in this phase and the procedures will be the same as Phase A.
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