Prader-Willi Syndrome Clinical Trial
Official title:
Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome
The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated.
The observational study will be carried out at the U.O. of Auxology, Istituto Auxologico Italiano, IRCCS, Piancavallo. 36 subjects with a genetic diagnosis of PWS, of both sexes and aged between 18 and 55, and their caregivers will be taken into consideration. In subjects affected by PWS, the following variables will be investigated: - anthropometric parameters (height, weight, BMI, waist circumference); - socio-demographic conditions (gender, age, origin, level of education, family composition) - concomitant hormonal and psychiatric therapies - intellectual profile through the Mini-Mental State Examination (MMSE), a neuropsychological test consisting of 30 items that refer to the following cognitive areas: orientation in time, orientation in space, word recording, attention and calculation, recall, language, constructional praxis. - psychological well-being through the Psychological General Well-Being Index (PGWBI), a questionnaire made up of 22 items that measure the following dimensions: anxiety, depression, positivity and well-being, self-control, general state of health, and vitality. - perception of life quality through the 36-Item Short Form Survey (SF-36), a questionnaire composed of 36 items that investigates the perception of quality of life in relation to: physical functioning, limitations due to physical health, limitations due to emotions, energy and fatigue, emotional well-being, social activities, pain, general health perception - mental distress through the Symptom Checklist-90-R (SCL-90-R), a questionnaire made up of 90 items capable of investigating the presence and severity of symptoms of mental distress related to nine psychopathological dimensions: somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, anger-hostility, phobic anxiety, paranoid ideation, psychoticism. The following variables will be investigated in the parents or caregivers of subjects with PWS: - psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21), a questionnaire composed of 21 items aimed at investigating experiences of anxiety, depression, and stress - psychological well-being through the Psychological General Well-Being Index (PGWBI), a questionnaire made up of 22 items that measure the following dimensions: anxiety, depression, positivity and well-being, self-control, general state of health, and vitality. - coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version). It is a questionnaire made up of 60 items aimed at investigating how often the subject implements - in difficult or stressful situations - different coping strategies to deal with stressful daily situations. - hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ), a questionnaire to be administered to parents or caregivers of reference consisting of 11 items capable of investigating the hyperphagia of subjects affected by PWS. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05032326 -
Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial
|
Phase 3 | |
| Completed |
NCT04526379 -
Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation
|
N/A | |
| Terminated |
NCT03458416 -
A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome
|
Phase 2 | |
| Completed |
NCT03718416 -
Natural History Study of Serious Medical Events in PWS
|
||
| Active, not recruiting |
NCT05322096 -
Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome
|
Phase 2 | |
| Terminated |
NCT02179151 -
Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome
|
Phase 3 | |
| Completed |
NCT02205450 -
Growth Hormone in Children Under 2 Years With Prader-Willi in Hospital of Sabadell
|
||
| Completed |
NCT00375089 -
Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity
|
N/A | |
| Completed |
NCT00004351 -
Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes
|
N/A | |
| Recruiting |
NCT05879614 -
An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001)
|
Phase 2 | |
| Recruiting |
NCT05938543 -
Cerebellar TMS and Satiety in Prader-Willi Syndrome
|
N/A | |
| Recruiting |
NCT03031626 -
Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome
|
Phase 4 | |
| Withdrawn |
NCT04086810 -
An Open-Label Study of DCCR Tablet in Patients With PWS
|
Phase 3 | |
| Completed |
NCT02629991 -
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
|
Phase 2 | |
| Recruiting |
NCT02297022 -
Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
|
Phase 1 | |
| Not yet recruiting |
NCT02263781 -
PREPL in Health and Disease
|
N/A | |
| Completed |
NCT00551343 -
Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome
|
N/A | |
| Enrolling by invitation |
NCT03655223 -
Early Check: Expanded Screening in Newborns
|
||
| Recruiting |
NCT05939453 -
Impact of Bright Light Therapy on Prader-Willi Syndrome
|
N/A | |
| Recruiting |
NCT04463316 -
GROWing Up With Rare GENEtic Syndromes
|