Development and Application of Comprehensive Intervention Techniques for Adolescent Depression

Depressive Disorder Clinical Trial

Official title:

Research and Application of Key Technologies for Early Identification, Risk Warning and Comprehensive Intervention of Adolescent Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945342
• Other study ID #: IIT2023510
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Huang, Manli, M.D
• Phone: 13957162975
• Email: huangmanli[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. The interaction of symptoms, psychological indicators (including environmental risk factors and neuropsychology), peripheral biology (peripheral neuroimmunity, neurotrophic factors and neuroendocrine related indicators), central biological indicators (neuroimaging, near-infrared functional brain imaging) and brain-derived exosome detection in peripheral blood was constructed based on artificial intelligence technology The network of clinical diagnosis platform, and according to the high and low suicide risk classification of deep learning, the establishment of adolescent depression early identification and suicide risk warning system.

2. To develop a simplified interpersonal psychotherapy technique (IPT-A) for adolescent depression.

3. Research and development of rTMS neuroregulation technology for precise positioning of robot navigation in adolescent depression.

4. Construct comprehensive intervention models and efficacy prediction models for adolescent depression, such as drug combined with psychology and drug combined with physical therapy, and promote and demonstrate the application.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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;

• 24 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Adolescent
• Depressive Disorder

Intervention

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

Other:
• Interpersonal Psychotherapy for Adolescent
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.
• Escitalopram combined with psychotherapy
The subjects received adolescent interpersonal psychotherapy for adolescent(IPT-A) while taking medication
• Escitalopram combined with rTMS
The subjects received Robotic navigational repetitive transcranial magnetic stimulation while taking medication

Drug:
• Escitalopram combined with sham rTMS
The subjects received sham Robotic navigational repetitive transcranial magnetic stimulation while taking medication

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of Child Depression Rating Scale-Revised	For clinical depression symptom assessment	Baseline, 2-week, 4-week, 8-week
Primary	Score of Beck Scale for Suicide Ideation	For the quantitative assessment of suicidal ideation	Baseline, 2-week, 4-week, 8-week
Primary	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
Primary	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
Primary	Hypocretin	Hypocretin is a neurotransmitter that regulates wakefulness and appetite	Baseline, 2-week, 8-week
Primary	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
Primary	Neuroimmune-related factors	Such as IL-lß?IL-6?TNF-a	Baseline, 2-week, 8-week
Primary	Neurotrophic pathway related factors	Such as BDNF?VGF?TrkB?tPA	Baseline, 2-week, 8-week
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Score of 24-item Hamilton Depression Rating Scale	For clinical depression symptom assessment	Baseline, 2-week, 4-week, 8-week
Secondary	Ottawa Self-injury Questionnaire	To evaluate the situation of NSSI among adolescents	Baseline, 2-week, 4-week, 8-week
Secondary	Score of Childhood Trauma Questionnaire	Used to assess traumatic experiences in childhood	Baseline