Development and Application of Comprehensive Intervention Techniques for Adolescent Depression

NCT05945342 | Recruiting

• 1 other identifier: IIT2023510
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In order to realize the early identification, risk warning and comprehensive intervention of adolescent depression, this project carried out research on the diagnosis platform of adolescent depression, the construction of suicide risk warning and evaluation system, the development of interpersonal psychotherapy technology (IPT-A), and the rapid intervention technology of robotic navigation repetitive transcranial magnetic stimulation (rTMS). Through the extraction of psychological, peripheral and central biological characteristics of adolescent depression and the establishment of a diagnostic platform, combined with artificial neural network to achieve efficient and accurate identification of high risk of suicide population. Antidepressant drugs combined with psychotherapy and antidepressant drugs combined with rTMS physical therapy were used to improve the clinical effective rate and recovery rate. Finally, a comprehensive prevention and control technology suitable for hospitals, schools and families to participate in.

Conditions

Depressive Disorder; Adolescent

Outcome Measures

Primary Outcomes (13)

• Score of Child Depression Rating Scale-Revised

  For clinical depression symptom assessment

  Baseline, 2-week, 4-week, 8-week

• Score of Beck Scale for Suicide Ideation

  For the quantitative assessment of suicidal ideation

  Baseline, 2-week, 4-week, 8-week

• Score of Iowa Gambling Task

  The simulation of the real decision situation is a kind of decision making task in the fuzzy situation accompanied by corresponding rewards and punishments

  Baseline, 2-week, 8-week

• Score of THINC-it test

  The test includes Spotter, Symbol check, Codebreaker, Trails, and the 5-item Depression Cognitive Deficit Questionnaire (PDQ-5-D). It is used to assess working memory, executive function and attention

  Baseline, 2-week, 8-week

• Hypocretin

  Hypocretin is a neurotransmitter that regulates wakefulness and appetite

  Baseline, 2-week, 8-week

• Endocannabinoid

  Endocannabinoid play an important role in regulating many functions in the body, including the inflammatory system, immune function, sleep, appetite, digestion, pain receptors, hormones, reproductive function and memory

  Baseline, 2-week, 8-week

• Neuroimmune-related factors

  Such as IL-lβ、IL-6、TNF-α

  Baseline, 2-week, 8-week

• Neurotrophic pathway related factors

  Such as BDNF、VGF、TrkB、tPA

  Baseline, 2-week, 8-week

• Near infrared functional imaging of the brain

  Near infrared functional brain imaging can reflect the activation degree of brain function and functional connectivity of brain by detecting the concentration changes of oxygenated hemoglobin and deoxygenated hemoglobin in the target brain area.

  Baseline, 2-week, 8-week

• Change in working memory test scores after intervention

  The working memory test consists of two parts, which measure the breadth and accuracy of working memory respectively. The breadth of working memory will be tested using the operating span experiment, as the accuracy of working memory will be tested using the Memory Orientation experiment

  Baseline, 2-week, 8-week, 24-week

• Change in three component test of executive function scores after intervention

  The three component tests of executive function were one-backward test, anti-saccade and shifting test respectively.In the one-backward test, subjects need to memorize letters while counting numbers, scoring them according to the accuracy of the alphabetic memory order; The anti-saccade test asks subjects to react to a flash of arrows (0.5 seconds) by selecting the direction they see on a keyboard；The shifting test asked subjects to select a forward or reverse feedback key depending on where the icon appeared

  Baseline, 2-week, 8-week, 24-week

• TMS-Evoked potential

  The integration of transcranial magnetic stimulation (TMS) and electroencephalography (EEG) is a valuable method for directly probing excitability, connectivity and oscillatory dynamics of regions throughout the brain. Offering in depth measurement of cortical reactivity, TMS-EEG allows the evaluation of TMS-evoked components that may act as a marker for cortical excitation and inhibition.

  Baseline, 2-week, 8-week

• Magnetic Resonance Imaging

  Functional magnetic resonance brain imaging can reflect the functional and metabolic information of neurons before morphological changes

  Baseline, 2-week, 8-week

Secondary Outcomes (3)

• Score of 24-item Hamilton Depression Rating Scale

  Baseline, 2-week, 4-week, 8-week

• Ottawa Self-injury Questionnaire

  Baseline, 2-week, 4-week, 8-week

• Score of Childhood Trauma Questionnaire

  Baseline

Study Arms (5)

Simple Medication

ACTIVE COMPARATOR

Escitalopram alone treatment

Drug: Escitalopram

Simple Psychotherapy

ACTIVE COMPARATOR

Simple interpersonal psychotherapy group

Other: Interpersonal Psychotherapy for Adolescent

Medication combined with psychotherapy

EXPERIMENTAL

Medication combined with interpersonal psychotherapy

Other: Escitalopram combined with psychotherapy

Medication combined with physical therapy group

EXPERIMENTAL

Medication combined with robotic navigational repetitive transcranial magnetic stimulation

Other: Escitalopram combined with rTMS

Medication combined with sham physical therapy group

SHAM COMPARATOR

Medication combined with sham robotic navigational repetitive transcranial magnetic stimulation

Drug: Escitalopram combined with sham rTMS

Interventions

Escitalopram DRUG

The US Food and Drug Administration(FDA) has only approved fluoxetine and escitalopram for the treatment of adolescent depression

Simple Medication

Interpersonal Psychotherapy for Adolescent OTHER

Interpersonal Psychotherapy for Adolescent(IPT-A), A modified version of interpersonal psychotherapy, is shorter than the standard therapy duration (12-16 sessions), with a total of eight sessions, retaining the structure of the standard IPT but employing a series of strategies to extract the most important components to speed up the time process.

Simple Psychotherapy

Escitalopram combined with psychotherapy OTHER

The subjects received adolescent interpersonal psychotherapy for adolescent(IPT-A) while taking medication

Medication combined with psychotherapy

Escitalopram combined with rTMS OTHER

The subjects received Robotic navigational repetitive transcranial magnetic stimulation while taking medication

Medication combined with physical therapy group

Escitalopram combined with sham rTMS DRUG

The subjects received sham Robotic navigational repetitive transcranial magnetic stimulation while taking medication

Medication combined with sham physical therapy group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Sign a written informed consent to participate in the trial and receive treatment;
• Meet the diagnostic criteria of depression in DSM-5, and have no psychotic characteristics;
• Child Depression Rating Scale-Revised (CRs-R)≥40 points;
• Hamilton Depression Scale (HAMD-24) scores ≥20;
• First or recurrent depressive episode, not received antidepressant drugs and systematic psychotherapy in recent 2 months;
• The Han nationality, right hand

You may not qualify if:

• Have other mental disorders, or have a history of other mental disorders, such as attention deficit movement disorder, autism, and developmental retardation;
• Patients with current infections, trauma, autoimmune diseases, other unstable medical conditions, or who are receiving hormone therapy;
• Patients with a history of craniocerebral injury and coma;
• A family history of bipolar disorder, seizures, or epilepsy;
• Those who had substance abuse or dependence within the first three months of enrollment;
• Patients with contraindications for MRI examination such as metal foreign body in the skull or abnormal brain structure found in MRI examination.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder

Interventions

Escitalopram; Interpersonal Psychotherapy; Psychotherapy; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Behavioral Disciplines and Activities; Magnetic Field Therapy; Therapeutics

Central Study Contacts

Huang, Manli, M.D

CONTACT

13957162975; huangmanli@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: July 14, 2023
• Study Start: January 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

CN (1)