Obesity Clinical Trial
— PWS-GXROfficial title:
A Double Blind, Placebo Controlled, Fixed-Flexible Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome
This is a placebo-controlled clinical trial to assess whether Guanfacine Extended Release (GXR) reduces aggression and self injurious behavior in individuals with Prader Willi Syndrome (PWS). In addition, the study will establish the safety of GXR with a specific focus on metabolic effects.
Status | Recruiting |
Enrollment | 33 |
Est. completion date | January 18, 2024 |
Est. primary completion date | January 18, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 35 Years |
Eligibility | Inclusion Criteria: - Diagnosis of PWS confirmed by genetic testing documentation - Rating of moderate or above on the Clinical Global Impression- Severity Scale Exclusion Criteria: - Subjects with positive pregnancy test, swallowing difficulty, and/or presenting with active psychosis or mania will be excluded - Subjects currently taking guanfacine extended release - Patients with lactose intolerance - Individuals with pre-existing, clinically significant bradycardia (< 8 years: <64 bpm; 8 to 12 years: <59 bpm; 12 to 16 years: <53 bpm) or hypotension, defined as 5th percentile for height and gender,26 will be excluded from the study. - Subjects receiving antipsychotic medications due to a documented history of psychosis or bipolar disorder will be allowed to continue taking the medication without dosage modification. - Growth hormone, thyroid hormone replacement treatment, and non-psychiatric medicines will be allowed to continue. - N-Acetyl Cysteine and anticonvulsant medication (only if prescribed for seizures) will be allowed to continue, with specific instructions to not make any dosage changes during the clinical trial. |
Country | Name | City | State |
---|---|---|---|
United States | Maimonides Medical Center | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
Maimonides Medical Center |
United States,
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. — View Citation
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Motov S, Rockoff B, Cohen V, Pushkar I, Likourezos A, McKay C, Soleyman-Zomalan E, Homel P, Terentiev V, Fromm C. Intravenous Subdissociative-Dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2015 Sep;66(3):222-229.e1. doi: 10.1016/j.annemergmed.2015.03.004. Epub 2015 Mar 26. — View Citation
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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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Global Impression- Improvement change from baseline to week 16 | Clinical Global Impression-Improvement is a 7 item scale. A rating of 0=not assessed, 1= very much improved, 2= much improved, 3=minimally improved, 4= no change, 5= minimally worse, 6= much worse, and 7= very much worse. Scores after "4" indicate a decreasing health outcome. Positive clinical response will be determined by a rating of 1= very much improved or 2= Much improved at the end of the blinded trial. | 16 Weeks | |
Secondary | A change in Aberrant Behavior Checklist from baseline to week 16 | Aberrant Behavior Checklist is a 58 item survey. Items are rated on 4 point scale, "0" indicates no problem, "3" indicates major problem. Higher scores are associated with greater severity. The scales are subdivided into 5 subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. | 16 Weeks | |
Secondary | A change in Self-Injury Trauma Scale from baseline to week 16 | Self Injury Trauma Scale is divided into three parts. Part 1 is an observation of healed injuries and identifying self injurious behaviors. Part 2 is subdivided into three parts number, type, and severity. Number is based on the number of wounds 1=one wound (common in a mild cases but rare in a severe case) 2=two or four wounds (common) and 3=five or more wounds (rare). Type is categorical and used to differentiate between abrasion/laceration and contusion. Injury severity is scored on a 3 item scale. "1" represents the least severe option and "3" represents the most severe option. Injury severity is broken down between type. Part 3 is the Estimate of Current Risk. It is assessed on a subjective basis with labels such as "mild", "moderate", and "severe" accompanied by descriptions of the observed state of the anatomy. Higher scores are associated with greater severity. | 16 Weeks | |
Secondary | A change in Modified Overt Aggression Scale from baseline to week 16 | Modified Overt Aggression Scale is a four-part behavior rating scale used to evaluate and document the "frequency and severity" of aggressive episodes. The rating scale is made up of four categories: verbal aggression, aggression against objects, aggression against self, and aggression against others. Each part is rated on a 5 point scale, "0" indicates no aggression, "4" indicates the most aggressive option. Higher scores are associated with greater severity. | 16 Weeks |
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