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The effects of atomoxitine and OROS-MPH on the emotional dysregulation in children with ADHD: a multi-center randomized controlled trial

The effects of atomoxitine and OROS-MPH on the emotional dysregulation in children with ADHD: a multi-center randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062905
Enrollment
Unknown
Registered
2022-08-23
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-Deficit/Hyperactivity Disorder

Interventions

Group 1:Treat with atomoxetine
Group 2:Treat with OROS-MPH

Sponsors

Peking University Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. Met the DSM-5 ADHD diagnostic criteria; 2. With emotional dysregulation; 3. 7-16 years old; 4. IQ>=80; 5. ADHD medication-naive or had stopped taking ADHD medications for at least six months; 6. Right-handed (only for children who participated in the MRI scan); 7. With informed consent.

Exclusion criteria

Exclusion criteria: 1. Schizophrenia, autism spectrum disorders, tic disorder; 2. Bipolar disorder, depressive disorders, anxiety disorders; 3. Who have narrow-angle glaucoma; 4. Who have dysphagia or severe gastrointestinal stenosis; 5. Who have been co-administered other psychotropic medications within the past 30 days or since the start of the study or those applying non-pharmacological treatments for ADHD; 6. With hypertension, cardiac insufficiency, tachyarrhythmias, and other cardiovascular diseases that are not suitable for experimental drug therapy; 7. Who participate in MRI scans should be excluded from having conditions that make them unsuitable for MRI.

Design outcomes

Primary

MeasureTime frame
emotion dysregulation symptom;

Secondary

MeasureTime frame
ADHD severity;Emotion regulation strategies;ADHD core symptoms;

Countries

China

Contacts

Public ContactLiu Lu

Peking University Sixth Hospital

liulupku@bjmu.edu.cn+86 134 2613 4210

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 12, 2026