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A Randomized Controlled Trial of Brexpiprazole versus Aripiprazole in the Treatment of Major Depressive Disorder with Psychotic Symptoms in Adolescents

A Randomized Controlled Trial of Brexpiprazole versus Aripiprazole in the Treatment of Major Depressive Disorder with Psychotic Symptoms in Adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117345
Enrollment
Unknown
Registered
2026-01-22
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Major Depressive Disorder with Psychotic Symptoms (MDD-PS)

Interventions

Control group:Aripiprazole combined with Brexpiprazole analog and Escitalopram
Study group:Brepiprazole in combination with Aripiprazole mimic and Escitalopram

Sponsors

Shandong mental health center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1.Meeting DSM-5 criteria for MDD-P (with psychotic features, confirmed by SCID-5-P); 2.Adolescents aged 13-17; 3.CGI-S >= 4, with a current episode lasting >= 4 weeks; 4.Obtain informed consent from the patient and their legal guardians;

Exclusion criteria

Exclusion criteria: 1.Subjects with a concomitant serious somatic disease; 2.Alcohol or other psychoactive substance abusers; 3.Presence of intellectual developmental disorders; 4.Those with other mental disorders (such as bipolar disorder, schizophrenia); 5.Previously known allergy to the study drug; 6.Other conditions that the investigator deems unsuitable for enrollment; 7.Pregnant and lactating women;

Design outcomes

Primary

MeasureTime frame
Psychotic Symptoms Rating Scale;Hamilton Depression Scale, HAMD-24;Hamilton Anxiety Scale,HAMA;Montgomery-Asberg Depression Rating Scale;

Secondary

MeasureTime frame
Barnes akathisia rating scale, BARS;Global Assessment Function;Clinical Global Impression.CGI;Treatment Emergent Symptom Scale,TESS;Self-Rating Anxiety Scale;

Countries

China

Contacts

Public ContactXin Li

Shandong mental health center

lixin_6688@126.com+86 18705317581

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026