This trial will study if a medication can reduce aggressive and self-harming behavior in people with PWS, and its safety, esp. its metabolic effects.
- Prader-Willi Syndrome
- Behavioral Symptoms
- Intellectual Disability
- Neurobehavioral Symptoms
- Neurologic Symptoms
- Nervous System Disorders
- Chromosome Disorder
- Antihypertensive Drugs
- Multiple Abnormalities
- Congenital Anomalies
- Genetic Disorders, Congenital
- Neurotransmitter Agents
- Molecular Pharmacology
- Drug Effects
- Skin Picking Disorder
2 Primary · 6 Secondary · Reporting Duration: 16 Weeks
Side Effects for
2 Treatment Groups
1 of 2
1 of 2
33 Total Participants · 2 Treatment Groups
Primary Treatment: GXR · Has Placebo Group · Phase 4
Who is running the clinical trial?
Age 6 - 35 · All Participants · 2 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Daly EJ, Trivedi MH, Janik A, Li H, Zhang Y, Li X, Lane R, Lim P, Duca AR, Hough D, Thase ME, Zajecka J, Winokur A, Divacka I, Fagiolini A, Cubala WJ, Bitter I, Blier P, Shelton RC, Molero P, Manji H, Drevets WC, Singh JB. Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Sep 1;76(9):893-903. doi: 10.1001/jamapsychiatry.2019.1189.
- Wajs E, Aluisio L, Holder R, Daly EJ, Lane R, Lim P, George JE, Morrison RL, Sanacora G, Young AH, Kasper S, Sulaiman AH, Li CT, Paik JW, Manji H, Hough D, Grunfeld J, Jeon HJ, Wilkinson ST, Drevets WC, Singh JB. Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2). J Clin Psychiatry. 2020 Apr 28;81(3):19m12891. doi: 10.4088/JCP.19m12891.
- Ochs-Ross R, Daly EJ, Zhang Y, Lane R, Lim P, Morrison RL, Hough D, Manji H, Drevets WC, Sanacora G, Steffens DC, Adler C, McShane R, Gaillard R, Wilkinson ST, Singh JB. Efficacy and Safety of Esketamine Nasal Spray Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression-TRANSFORM-3. Am J Geriatr Psychiatry. 2020 Feb;28(2):121-141. doi: 10.1016/j.jagp.2019.10.008. Epub 2019 Oct 17.
- Ketterer MW, Brymer J, Rhoads K, Kraft P, Lovallo WR. Is aspirin, as used for antithrombosis, an emotion-modulating agent? J Psychosom Res. 1996 Jan;40(1):53-8. doi: 10.1016/0022-3999(95)00524-2.
- Mendlewicz J, Kriwin P, Oswald P, Souery D, Alboni S, Brunello N. Shortened onset of action of antidepressants in major depression using acetylsalicylic acid augmentation: a pilot open-label study. Int Clin Psychopharmacol. 2006 Jul;21(4):227-31. doi: 10.1097/00004850-200607000-00005.
- Ng QX, Ramamoorthy K, Loke W, Lee MWL, Yeo WS, Lim DY, Sivalingam V. Clinical Role of Aspirin in Mood Disorders: A Systematic Review. Brain Sci. 2019 Oct 29;9(11):296. doi: 10.3390/brainsci9110296.
- Marland S, Ellerton J, Andolfatto G, Strapazzon G, Thomassen O, Brandner B, Weatherall A, Paal P. Ketamine: use in anesthesia. CNS Neurosci Ther. 2013 Jun;19(6):381-9. doi: 10.1111/cns.12072. Epub 2013 Mar 22.
- Motov, Sergey, Bradley Rockoff, Victor Cohen, Illya Pushkar, Antonios Likourezos, Courtney McKay, Emil Soleyman-Zomalan, Peter Homel, Victoria Terentiev, and Christian Fromm. 2015. “Intravenous Subdissociative-dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial”. Annals of Emergency Medicine. Elsevier BV. doi:10.1016/j.annemergmed.2015.03.004.
- 2020. "Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05657860.
Frequently Asked Questions
Are juveniles of a certain age qualified to participate in this experiment?
"This research is open to applicants aged between 6 and 35 years old." - Anonymous Online Contributor
Who has the opportunity to take part in this examination?
"To qualify for this medical trial, applicants must have a neurodegenerative disease and be between 6-35 years old. 33 individuals are accepted in total." - Anonymous Online Contributor
Has GXR attained regulatory clearance from the FDA?
"Our assessment at Power rates the safety of GXR as a 3, since this is an approved Phase 4 trial which has already been deemed safe for general use." - Anonymous Online Contributor
What is the overall size of this research project's participant pool?
"Affirmative. Clinicaltrials.gov showcases that this medical trial is currently looking for participants; the initial posting was on December 17th 2020 and there has since been a recent update on December 12th 2022. This study requires recruitment of 33 individuals from 1 location." - Anonymous Online Contributor
Are there any vacancies for participation in this trial?
"Affirmative, clinicaltrials.gov data indicates that this medical trial is presently in search of participants. Begun on December 17th 2020 and most recently updated on the 12th of December 2022, 33 patients are being invited to join from a single facility." - Anonymous Online Contributor