- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05945342
Development and Application of Comprehensive Intervention Techniques for Adolescent Depression
March 20, 2024 updated by: First Affiliated Hospital of Zhejiang University
Research and Application of Key Technologies for Early Identification, Risk Warning and Comprehensive Intervention of Adolescent Depression
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
- 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.
- To develop a simplified interpersonal psychotherapy technique (IPT-A) for adolescent depression.
- Research and development of rTMS neuroregulation technology for precise positioning of robot navigation in adolescent depression.
- 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.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huang, Manli, M.D
- Phone Number: 86 13957162975
- Email: huangmanli@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Recruiting
- The First Affiliated Hospital of Zhejiang University
-
Contact:
- Huang Manli
- Phone Number: 13957162975
- Email: huangmanli@zju.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Simple Psychotherapy
Simple interpersonal psychotherapy group
|
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.
|
Experimental: Medication combined with psychotherapy
Medication combined with interpersonal psychotherapy
|
The subjects received adolescent interpersonal psychotherapy for adolescent(IPT-A) while taking medication
|
Experimental: Medication combined with physical therapy group
Medication combined with robotic navigational repetitive transcranial magnetic stimulation
|
The subjects received Robotic navigational repetitive transcranial magnetic stimulation while taking medication
|
Sham Comparator: Medication combined with sham physical therapy group
Medication combined with sham robotic navigational repetitive transcranial magnetic stimulation
|
The subjects received sham Robotic navigational repetitive transcranial magnetic stimulation while taking medication
|
Active Comparator: Simple Medication
Escitalopram alone treatment
|
The US Food and Drug Administration(FDA) has only approved fluoxetine and escitalopram for the treatment of adolescent depression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score of Child Depression Rating Scale-Revised
Time Frame: Baseline, 2-week, 4-week, 8-week
|
For clinical depression symptom assessment
|
Baseline, 2-week, 4-week, 8-week
|
Score of Beck Scale for Suicide Ideation
Time Frame: Baseline, 2-week, 4-week, 8-week
|
For the quantitative assessment of suicidal ideation
|
Baseline, 2-week, 4-week, 8-week
|
Score of Iowa Gambling Task
Time Frame: Baseline, 2-week, 8-week
|
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
Time Frame: Baseline, 2-week, 8-week
|
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
Time Frame: Baseline, 2-week, 8-week
|
Hypocretin is a neurotransmitter that regulates wakefulness and appetite
|
Baseline, 2-week, 8-week
|
Endocannabinoid
Time Frame: Baseline, 2-week, 8-week
|
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
Time Frame: Baseline, 2-week, 8-week
|
Such as IL-lβ、IL-6、TNF-α
|
Baseline, 2-week, 8-week
|
Neurotrophic pathway related factors
Time Frame: Baseline, 2-week, 8-week
|
Such as BDNF、VGF、TrkB、tPA
|
Baseline, 2-week, 8-week
|
Near infrared functional imaging of the brain
Time Frame: Baseline, 2-week, 8-week
|
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
Time Frame: Baseline, 2-week, 8-week, 24-week
|
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
Time Frame: Baseline, 2-week, 8-week, 24-week
|
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
Time Frame: Baseline, 2-week, 8-week
|
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
Time Frame: Baseline, 2-week, 8-week
|
Functional magnetic resonance brain imaging can reflect the functional and metabolic information of neurons before morphological changes
|
Baseline, 2-week, 8-week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score of 24-item Hamilton Depression Rating Scale
Time Frame: Baseline, 2-week, 4-week, 8-week
|
For clinical depression symptom assessment
|
Baseline, 2-week, 4-week, 8-week
|
Ottawa Self-injury Questionnaire
Time Frame: Baseline, 2-week, 4-week, 8-week
|
To evaluate the situation of NSSI among adolescents
|
Baseline, 2-week, 4-week, 8-week
|
Score of Childhood Trauma Questionnaire
Time Frame: Baseline
|
Used to assess traumatic experiences in childhood
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2023
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
May 5, 2023
First Submitted That Met QC Criteria
July 13, 2023
First Posted (Actual)
July 14, 2023
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Mood Disorders
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Selective Serotonin Reuptake Inhibitors
- Citalopram
- Dexetimide
- Escitalopram
Other Study ID Numbers
- IIT2023510
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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