Adjunctive iTBS for First-Episode Schizophrenia

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Schizophrenia Disorder
Interventions
DEVICE

Intermittent Theta-Burst Stimulation (iTBS)

Stimulation delivered using a Magstim RAPID2 stimulator. The target was the left DLPFC (F3 position). The protocol consisted of 20 sessions (5 days/week for 4 weeks) at 100% of the individual's motor threshold (MT), with each session delivering 2400 pulses.

DRUG

Risperidone

Oral risperidone (Jiangsu Enhua Pharmaceutical Co., Ltd.) initiated at 1 mg/day and flexibly titrated based on efficacy and tolerability to a maximum of 6 mg/day.

BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

Manualized CBT administered twice weekly for 12 weeks. The therapy comprised an initial individual phase (4 weeks) focusing on psychoeducation and a subsequent group phase (8 weeks) targeting social and emotional skills.

Trial Locations (1)

050000

The First Hospital of Hebei Medical University, Shijiazhuang

All Listed Sponsors
lead

The First Hospital of Hebei Medical University

OTHER

NCT07116850 - Adjunctive iTBS for First-Episode Schizophrenia | Biotech Hunter | Biotech Hunter