Back to resultsDevelopment and Application of Comprehensive Intervention Techniques for Adolescent Depression
Primary Purpose
Depressive Disorder, Adolescent
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fluoxetine
Interpersonal Psychotherapy for Adolescent
Fluoxetine combined with psychotherapy
Fluoxetine combined with rTMS
Fluoxetine combined with sham rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital of Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Sham Comparator
Arm Label
Simple Medication
Simple Psychotherapy
Medication combined with psychotherapy
Medication combined with physical therapy group
Medication combined with sham physical therapy group
Arm Description
Fluoxetine alone treatment
Simple interpersonal psychotherapy group
Medication combined with interpersonal psychotherapy
Medication combined with robotic navigational repetitive transcranial magnetic stimulation
Medication combined with sham robotic navigational repetitive transcranial magnetic stimulation
Outcomes
Primary Outcome Measures
Score of Child Depression Rating Scale-Revised
For clinical depression symptom assessment
Score of Beck Scale for Suicide Ideation
For the quantitative assessment of suicidal ideation
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
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
Hypocretin
Hypocretin is a neurotransmitter that regulates wakefulness and appetite
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
Neuroimmune-related factors
Such as IL-lβ、IL-6、TNF-α
Neurotrophic pathway related factors
Such as BDNF、VGF、TrkB、tPA
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.
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
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
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.
Magnetic Resonance Imaging
Functional magnetic resonance brain imaging can reflect the functional and metabolic information of neurons before morphological changes
Secondary Outcome Measures
Score of 24-item Hamilton Depression Rating Scale
For clinical depression symptom assessment
Ottawa Self-injury Questionnaire
To evaluate the situation of NSSI among adolescents
Score of Childhood Trauma Questionnaire
Used to assess traumatic experiences in childhood
Full Information
NCT ID
NCT05945342
First Posted
May 5, 2023
Last Updated
July 13, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05945342
Brief Title
Development and Application of Comprehensive Intervention Techniques for Adolescent Depression
Official Title
Research and Application of Key Technologies for Early Identification, Risk Warning and Comprehensive Intervention of Adolescent Depression
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Simple Medication
Arm Type
Active Comparator
Arm Description
Fluoxetine alone treatment
Arm Title
Simple Psychotherapy
Arm Type
Active Comparator
Arm Description
Simple interpersonal psychotherapy group
Arm Title
Medication combined with psychotherapy
Arm Type
Experimental
Arm Description
Medication combined with interpersonal psychotherapy
Arm Title
Medication combined with physical therapy group
Arm Type
Experimental
Arm Description
Medication combined with robotic navigational repetitive transcranial magnetic stimulation
Arm Title
Medication combined with sham physical therapy group
Arm Type
Sham Comparator
Arm Description
Medication combined with sham robotic navigational repetitive transcranial magnetic stimulation
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
The US Food and Drug Administration(FDA) has only approved fluoxetine and escitalopram for the treatment of adolescent depression
Intervention Type
Other
Intervention Name(s)
Interpersonal Psychotherapy for Adolescent
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fluoxetine combined with psychotherapy
Intervention Description
The subjects received adolescent interpersonal psychotherapy for adolescent(IPT-A) while taking medication
Intervention Type
Other
Intervention Name(s)
Fluoxetine combined with rTMS
Intervention Description
The subjects received Robotic navigational repetitive transcranial magnetic stimulation while taking medication
Intervention Type
Drug
Intervention Name(s)
Fluoxetine combined with sham rTMS
Intervention Description
The subjects received sham Robotic navigational repetitive transcranial magnetic stimulation while taking medication
Primary Outcome Measure Information:
Title
Score of Child Depression Rating Scale-Revised
Description
For clinical depression symptom assessment
Time Frame
Baseline, 2-week, 4-week, 8-week
Title
Score of Beck Scale for Suicide Ideation
Description
For the quantitative assessment of suicidal ideation
Time Frame
Baseline, 2-week, 4-week, 8-week
Title
Score of Iowa Gambling Task
Description
The simulation of the real decision situation is a kind of decision making task in the fuzzy situation accompanied by corresponding rewards and punishments
Time Frame
Baseline, 2-week, 8-week
Title
Score of THINC-it test
Description
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
Time Frame
Baseline, 2-week, 8-week
Title
Hypocretin
Description
Hypocretin is a neurotransmitter that regulates wakefulness and appetite
Time Frame
Baseline, 2-week, 8-week
Title
Endocannabinoid
Description
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
Time Frame
Baseline, 2-week, 8-week
Title
Neuroimmune-related factors
Description
Such as IL-lβ、IL-6、TNF-α
Time Frame
Baseline, 2-week, 8-week
Title
Neurotrophic pathway related factors
Description
Such as BDNF、VGF、TrkB、tPA
Time Frame
Baseline, 2-week, 8-week
Title
Near infrared functional imaging of the brain
Description
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.
Time Frame
Baseline, 2-week, 8-week
Title
Change in working memory test scores after intervention
Description
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
Time Frame
Baseline, 2-week, 8-week, 24-week
Title
Change in three component test of executive function scores after intervention
Description
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
Time Frame
Baseline, 2-week, 8-week, 24-week
Title
TMS-Evoked potential
Description
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.
Time Frame
Baseline, 2-week, 8-week
Title
Magnetic Resonance Imaging
Description
Functional magnetic resonance brain imaging can reflect the functional and metabolic information of neurons before morphological changes
Time Frame
Baseline, 2-week, 8-week
Secondary Outcome Measure Information:
Title
Score of 24-item Hamilton Depression Rating Scale
Description
For clinical depression symptom assessment
Time Frame
Baseline, 2-week, 4-week, 8-week
Title
Ottawa Self-injury Questionnaire
Description
To evaluate the situation of NSSI among adolescents
Time Frame
Baseline, 2-week, 4-week, 8-week
Title
Score of Childhood Trauma Questionnaire
Description
Used to assess traumatic experiences in childhood
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huang, Manli, M.D
Phone
13957162975
Ext
86
Email
huangmanli@zju.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Manli
Phone
13957162975
Email
huangmanli@zju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Development and Application of Comprehensive Intervention Techniques for Adolescent Depression
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