aiTBS for Relieving NSSI in Depressive Patients

NCT05384405 | Recruiting

• 1 other identifier: TMS20220425
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) has been successfully used to help patients with treatment resistant depression. However, its role in alleviating self injuries without suicidal ideation remained uncertain. This trial will compare the effectiveness of active accelerated intermittent theta burst stimulation (aiTBS) rTMS to a placebo control on non-suicidal self injury (NSSI) in patients with unipolar disorder and bipolar disorder.

Conditions

Major Depressive Disorder; Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Changes in the Deliberate Self-Harm Inventory (DSHI)

  Containing one subscale ranging from 0 to 57 to measure the frequencies of NSSI behavior and one subscale ranging from 0 to 76 to measure the severity of NSSI behavior.

  Baseline, after 5 treatment days, 2 week and 4 week post-treatment

Secondary Outcomes (12)

• Changes in Pittsburgh Sleep Quality Index (PSQI)

  Baseline, after 5 treatment days, 2 week and 4 week post-treatment

• Changes in Hamilton Anxiety Scale (HAMA)

  Baseline, after 5 treatment days, 2 week and 4 week post-treatment

• Changes in Young's Mania Scale (YMRS)

  Baseline, after 5 treatment days, 2 week and 4 week post-treatment

• Changes in Barratt Impulsiveness Scale-11 (BIS-11)

  Baseline, after 5 treatment days, 2 week and 4 week post-treatment

• Changes in cerebral blood flow of PFC through Near Infrared Spectroscopy (fNIRS)

  Baseline, after 5 treatment days

Other Outcomes (5)

• The retrospect of NSSI behavior

  Baseline

• Borderline features of patients with NSSI

  Baseline

• Child maltreatment of patients with NSSI

  Baseline

Study Arms (2)

active stimulation

ACTIVE COMPARATOR

Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.

Device: Active iTBS

Sham stimulation

SHAM COMPARATOR

Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.

Device: Sham iTBS

Interventions

Active iTBS DEVICE

MagPro X100

active stimulation

Sham iTBS DEVICE

MagPro X100

Sham stimulation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Documentation of DSM-5 criteria for current major depressive disorder (MDD) or bipolar disorder (BD) will be required for study entry.
• Ages between 12 and 18 years
• At least 1 caregivers to supervise the patient within 3 month.
• A score of greater than 17 on the HAM-D17.
• Occurrences of self injury behavior consistent with the DSM-5 criteria of NSSI more than 3 times in a month.
• Willingness to participate in the study and sign informed consents

You may not qualify if:

• Substance abusers such as psychoactive drugs or alcohol.
• Severe physical disability and unable to complete follow-up.
• Comorbid other major mental illnesses that meet the DSM-5 criteria, such as schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.
• Currently in a manic episode, YMRS\>12; rapid-cycling bipolar disorder, bipolar disorder with mixed features.
• Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
• Unable to read, understand and complete the assessment or to cooperate with the investigators.
• Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for rTMS.
• A history or family history of epilepsy and other contraindications to TMS.
• Daily use of benzodiazepines (more than 2mg/d), theophylline, stimulants such as methylphenidate, anticonvulsants, bupropion, etc.
• Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) within 3 months before baseline.
• Other examination abnormalities considered to be inappropriate by investigators.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Mental Health Institute of Second Xiangya Hospital,CSU

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Central Study Contacts

Renrong Wu, M.D. Ph.D

CONTACT

+8615874179855; wurenrong@csu.edu.cn

Jing Huang, M.D.

CONTACT

jinghuangserena001@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled clinical trial testing iTBS versus sham

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 20, 2022
• Study Start: July 1, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)