Clinical trials: Irritability, open to volunteers
Crohn Disease, Ulcerative Colitis
Safety and Efficacy of Fecal Microbiota Transplantation
The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease…
- Conditions
- Crohn Disease, Ulcerative Colitis, Celiac Disease, Irritable Bowel Syndrome
- Trial name
- NCT04014413
- Testing
- Fecal Microbiota Transplantation
- Where
- Hong Kong
- Volunteers
- 450 people
- Sponsor
- Chinese University of Hong Kong
Prader-Willi Syndrome
A Study of Pitolisant in Patients With Prader-Willi Syndrome
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.
- Trial name
- NCT06366464
- Testing
- Pitolisant tablet
- Where
- 57 sites in United States, Australia and 11 more
- Volunteers
- 134 people
- Sponsor
- Harmony Biosciences Management, Inc.
Diabetes Mellitus, Type 2, End Stage Renal Disease
Drug Interaction Potential of Pro-Inflammatory Conditions
Pro-inflammatory cytokines, which are elevated in pro-inflammatory disease states (e.g., type II diabetes mellitus [T2DM], irritable bowel diseases [IBD], and end stage renal disease [ESRD]) have been shown to inhibit hepatic…
- Conditions
- Diabetes Mellitus, Type 2, End Stage Renal Disease, Irritable Bowel Syndrome
- Trial name
- DIPPIC (NCT07360938)
- Testing
- None (Observational)
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Indiana University
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
This study was designed to determine whether vitamin D supplementation improved symptoms in children with irritable bowel syndrome, a condition associated with repeated abdominal pain and changes in bowel habits.
- Trial name
- NCT07914478
- Testing
- Vitamin D3
- Where
- Pakistan
- Volunteers
- 48 people
- Sponsor
- Aziz Bhatti Shaheed Teaching Hospital
Attention Deficit/Hyperactivity Disorder, Emotional Dysfunction
Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)
Evaluate feasibility and acceptability of recruiting Black and Hispanic families for an open label clinical trial of multinutrients while collecting real-time parent-reported child behavior data and collecting at-home…
- Conditions
- Attention Deficit/Hyperactivity Disorder, Emotional Dysfunction, Irritable Mood
- Trial name
- FAST (NCT06133231)
- Testing
- Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Oregon Health and Science University
ADHD - Attention Deficit Disorder With Hyperactivity, Irritability
Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants
Impulsive Aggression and chronic irritability (IACI) often occur together and are one of the most common reasons children present for behavioral health (BH) care.
- Conditions
- ADHD - Attention Deficit Disorder With Hyperactivity, Irritability, Aggression Childhood
- Trial name
- NCT06871488
- Testing
- CNS Stimulant, CNS Stimulant open label first phase
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Milton S. Hershey Medical Center
Prebiotic, IBS (Irritable Bowel Syndrome)
Psyllium Husk in Pediatric IBS
Children aged 6 to 17 years with IBS will be randomly assigned to either receive psyllium husk supplementation in addition to usual care or receive usual care alone.
- Conditions
- Prebiotic, IBS (Irritable Bowel Syndrome), Psyllium, Quality of Life (QOL)
- Trial name
- NCT07880327
- Testing
- Psyllium Husk, Conventional therapy group
- Volunteers
- 70 people
- Sponsor
- Eman ElHaddad
Disruptive Behavior Disorders, Conduct Disorder
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Background: Pediatric disruptive behavior disorders (DBDs) are characterized by severe irritability, anger, and temper outbursts. The primary way to treat children with DBDs is parent management training (PMT).
- Conditions
- Disruptive Behavior Disorders, Conduct Disorder, Oppositional Defiant Disorder, Attention-deficit/Hyperactivity Disorder
- Trial name
- NCT07764536
- Testing
- Psychotherapy
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- National Institute of Mental Health (NIMH)
Irritability Associated With Autism Spectrum Disorder
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
- Trial name
- NCT07285798
- Testing
- KarXT, KarX-EC
- Where
- 67 sites in United States, France and 8 more
- Volunteers
- 176 people
- Sponsor
- Bristol-Myers Squibb
Depression - Major Depressive Disorder, Irritability
Teen Vulnerability to Irritability: Brain and Estrogen Changes
Purpose: Risk of severe psychopathology increases dramatically during adolescence, especially for females. Changes in ovarian steroids across the menstrual cycle produce windows of vulnerability to mood disturbances, particularly…
- Trial name
- TeenVIBE (NCT07544966)
- Testing
- Kurvelo
- Where
- 2 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Schizophrenia, Autism-Related Irritability
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents
- Trial name
- NCT07424404
- Testing
- KarXT, KarX-EC
- Where
- 105 sites in United States, Australia and 9 more
- Volunteers
- 400 people
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Irritability Associated With Autism Spectrum Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and…
- Trial name
- NCT06690398
- Testing
- Lumateperone high dose, Lumateperone low dose
- Where
- 39 sites in United States, Serbia
- Volunteers
- 160 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Endometriosis, Bowels Irritable
Impact of Dietary Guidance and Probiotics in the Treatment of Endometriosis and Irritable Bowel Syndrome in Women
Patients with endometriosis are 2 to 3 times more likely to develop Irritable Bowel Syndrome (IBS) than women without the condition.
- Trial name
- NCT07149519
- Testing
- probiotics - Lactobacillus spp
- Where
- Brazil
- Volunteers
- 74 people
- Sponsor
- University of Sao Paulo
Irritability Associated With Autism Spectrum Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and…
- Trial name
- NCT06706674
- Testing
- Lumateperone high dose, Lumateperone low dose
- Where
- 41 sites in United States
- Volunteers
- 160 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Behavioral Problem, Irritable Mood
Stop, Focus, Plan, and Change: Predicting Parent and Child Responses to a Brief, Telehealth Parent Training
This study will look at who does not improve after doing a behavioral parent training program briefly through telehealth. It will also study ways to make the intervention better for those that do not improve.
- Conditions
- Behavioral Problem, Irritable Mood, Parenting, Stress
- Trial name
- NCT06505980
- Testing
- Brief Behavioral Parenting Program
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Irritable Bowel Disease, Functional Abdominal Pain - Not Otherwise Specified (FAP-NOS)
Pain in Pediatric Patients - Internet Interventions for Disorders of Gut-brain Interaction
Many children and adolescents often experience long-lasting stomach pain. In many cases, this is due to disorders of gut-brain interaction (DGBI), such as irritable bowel syndrome (IBS), functional abdominal pain, and functional…
- Conditions
- Irritable Bowel Disease, Functional Abdominal Pain - Not Otherwise Specified (FAP-NOS), Functional Dyspepsia
- Trial name
- PIPPI (NCT07319078)
- Testing
- Gut-directed hypnotherapy, Cognitive-behavioral therapy
- Where
- Sweden
- Volunteers
- 200 people
- Sponsor
- Karolinska Institutet
Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS)
Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders. One approach to treating these disorders is by using psychological therapies.
- Conditions
- Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Gastrointestinal Disorders (FGIDs), Gastrointestinal and Digestive Disorder
- Trial name
- NCT07222943
- Testing
- Guided Imagery Therapy
- Where
- 2 sites in United States
- Volunteers
- 63 people
- Sponsor
- Baylor College of Medicine
Behavior Problem of Childhood and Adolescence, Parent Management Training
Behavioral Parent Training With and Without AI Support for Children With Disruptive Behaviors
The goal of this clinical trial is to learn if adding an artificial intelligence (AI) application called to standard Behavioral Parent Training (BPT) helps families with children who have disruptive behavior problems.
- Conditions
- Behavior Problem of Childhood and Adolescence, Parent Management Training, Artificial Intelligence (AI), Disruptive Behaviours
- Trial name
- NCT07469215
- Testing
- Behavioral Parent Training (BPT), Behavioral Parent Training (BPT) + Support of AI app
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Fundació Sant Joan de Déu
Irritability, Disruptive Mood Dysregulation Disorder
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Background: Irritability is defined as proneness to anger that may impair a person's ability to function. It is a common reason for why some children need mental health care.
- Conditions
- Irritability, Disruptive Mood Dysregulation Disorder, Oppositional Defiant Disorder, Attention Deficit Hyperactivity Disorder
- Trial name
- NCT07640802
- Testing
- Psychotherapy
- Where
- United States
- Volunteers
- 410 people
- Sponsor
- National Institute of Mental Health (NIMH)
Neurodevelopmental Disorders, Irritability
AP Metabolism Transcriptomics
It is known from the literature that treatment with antipsychotic drugs (AP) induces, even before changes in blood chemistry parameters, changes in gene transcription that are evident at the level of peripheral blood mononuclear…
- Trial name
- NCT06814314
- Testing
- Transcriptomic investigation
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Eugenio Medea