Clinical trials: Pediatric Psychiatric Disorder
Bipolar Disorder
Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)
This study will investigate the safety and tolerability of a flexible dosing regimen of asenapine for the long-term treatment of manic or mixed episodes associated with bipolar disorder I in children and adolescents who completed…
- Trial name
- ADDRESS-98 (NCT01349907)
- Testing
- Asenapine, Rescue medication
- Volunteers
- 322 people
- Sponsor
- Organon and Co
Schizophrenia
Pediatric Schizophrenia Efficacy and Safety Study
Efficacy and Safety study of Lurasidone in pediatric patients.
- Trial name
- NCT01911429
- Testing
- Lurasidone 40 mg, Lurasidone 80 mg
- Where
- 90 sites in United States, Belgium and 15 more
- Volunteers
- 327 people
- Sponsor
- Sumitomo Pharma America, Inc.
Restless Legs Syndrome
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
- Trial name
- NCT02231918
- Testing
- MIRAPEX® - low, MIRAPEX® - medium, MIRAPEX® - high
- Volunteers
- 26 people
- Sponsor
- Boehringer Ingelheim
Autistic Disorder, Autism
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder…
- Conditions
- Autistic Disorder, Autism, Asperger's Disorder, Asperger Syndrome
- Trial name
- NCT01592747
- Testing
- Memantine Hydrochloride (HCl)
- Where
- 94 sites in United States, Belgium and 13 more
- Volunteers
- 479 people
- Sponsor
- Forest Laboratories
Attention Deficit Hyperactivity Disorder
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of…
- Trial name
- Zolkids (NCT00318448)
- Testing
- Zolpidem (SL800750)
- Where
- 2 sites in United States, Canada
- Volunteers
- 201 people
- Sponsor
- Sanofi
Down Syndrome, Cognitive Dysfunction
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10
The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome, aged 6 to 10 years.
- Trial name
- NCT00754013
- Testing
- Aricept (Donepezil hydrochloride)
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Eisai Inc.
Attention Deficit Hyperactivity Disorder
Dasotraline Pediatric ADHD Study
This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD.
- Trial name
- NCT02428088
- Testing
- Dasotraline
- Where
- 43 sites in United States
- Volunteers
- 330 people
- Sponsor
- Sumitomo Pharma America, Inc.
Attention Deficit Hyperactivity Disorder (ADHD)
A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants
The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder…
- Trial name
- NCT01933880
- Testing
- Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH), No intervention
- Where
- 6 sites in China
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
Rett Syndrome
Safety and Preliminary Efficacy of TSHA-102 Gene Therapy in Pediatric Females Aged >2 to <4 Years With Rett Syndrome
The primary objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of a single intrathecal (IT) dose of TSHA-102 in pediatric females with typical Rett syndrome.
- Trial name
- ASPIRE (NCT07480564)
- Testing
- TSHA-102
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Taysha Gene Therapies, Inc.
Pediatric Acute-Onset Neuropsychiatric Syndrome, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections
A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
This study will evaluate the use of intravenous immunoglobulins (IVIG) at a dose of 1g/Kg/body weight given every three weeks for 6 infusions in pediatric subjects ages 4 - 16 years with moderate to severe PANS.
- Trial name
- PANS (NCT03348618)
- Testing
- IVIG
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- IMMUNOe Research Centers
Cerebral Palsy, Neurological Conditions
Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions
This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions.
- Conditions
- Cerebral Palsy, Neurological Conditions, Mental Retardation, Sialorrhea
- Trial name
- NCT00491894
- Testing
- Oral Glycopyrrolate Liquid
- Where
- 7 sites in United States
- Volunteers
- 137 people
- Sponsor
- Shionogi
Schizophrenia
Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®
The purpose of this study is to determine if NaBen® is a safe and effective add-on treatment for schizophrenia in adolescents.
- Trial name
- NCT01908192
- Testing
- NaBen®
- Where
- 23 sites in United States, Taiwan
- Volunteers
- 60 people
- Sponsor
- SyneuRx International (Taiwan) Corp
Schizophrenia, Mania
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
- Trial name
- NCT00102479
- Testing
- Aripiprazole
- Volunteers
- 21 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Anxiety Disorders, Childhood Mental Disorder
Family-Focused CBT Skills App and Standard Self Help Options for Childhood Anxiety
Anxiety disorders are among the most common psychological disorders, with prevalent onset in childhood and adolescence. While cognitive behavioral therapy (CBT) is considered the first-line treatment for pediatric anxiety…
- Conditions
- Anxiety Disorders, Childhood Mental Disorder, Anxiety
- Trial name
- NCT03269370
- Testing
- Anchors Away, Parent Enhanced Anchors Away, Self-Help E-Book
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Kansas City Center for Anxiety Treatment, P.A.
Major Depressive Disorder
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
The main aim of the study is to check how well vortioxetine 10 mg/day or 20 mg/day works and to check for side effects compared to a placebo on depression symptoms in Japanese teenagers aged 12 to 17 years with a diagnosis of…
- Trial name
- NCT07204314
- Testing
- Vortioxetine tablets
- Where
- 30 sites in Japan
- Volunteers
- 180 people
- Sponsor
- Takeda
Rett Syndrome
A Safety Study of NNZ-2566 in Pediatric Rett Syndrome
The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of Rett syndrome in children and adolescents.
- Trial name
- NCT02715115
- Testing
- NNZ-2566
- Where
- 12 sites in United States
- Volunteers
- 82 people
- Sponsor
- Neuren Pharmaceuticals Limited
Attention Deficit Hyperactivity Disorder
Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)
- Trial name
- NCT00568685
- Testing
- Atomoxetine Hydrochloride
- Where
- 3 sites in South Korea
- Volunteers
- 153 people
- Sponsor
- Eli Lilly and Company
Autism, Autism Spectrum Disorder
Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11.
- Conditions
- Autism, Autism Spectrum Disorder, Autism Spectrum Disorder (ASD), Neurodevelopmental Conditions
- Trial name
- NCT07590973
- Testing
- BlinkLab Dx1, Retrospective Neurodevelopmental Diagnostic Assessment
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Blinklab Limited
Sialorrhea, Neurodevelopmental Disorders
Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Efficacy and Safety of Sialanar Plus orAl rehabiLitation Against Placebo Plus Oral Rehabilitation for chIldren and Adolescents With seVere Sialorrhoea and Neurodisabilties,
Double blind, placebo-controlled, randomised trial, multicentre in France with open-label tolerability phase. The double-blind placebo-controlled study duration will be scheduled for 3 months with the final visit of the…
- Trial name
- SALIVA (NCT04873115)
- Testing
- Sialanar, Oral Rehabilitation
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Proveca Pharma Limited
Autism Spectrum Disorder (ASD)
A Repeatability and Reproducibility Study of the EarliPoint™ Device
The study is a prospective randomized repeatability and reproducibility (R\&R) study of the EarliPoint DeviceTM in pediatric subjects 16-30 months of age.
- Trial name
- RnR (NCT04860986)
- Testing
- EarliPoint
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- EarliTec Diagnostics, Inc