Depressive DisorderNCT05945342
Development and Application of Comprehensive Intervention Techniques for Adolescent Depression
A study testing Escitalopram, Interpersonal Psychotherapy for Adolescent and Escitalopram combined with psychotherapy in people with Depressive Disorder and Adolescent, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Adolescent
- What is being tested?
- Escitalopram, Interpersonal Psychotherapy for Adolescent and Escitalopram combined with psychotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
Huang Manli, 13957162975, huangmanli@zju.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Depressive Disorder, Adolescent
- Being tested
- Escitalopram, Interpersonal Psychotherapy for Adolescent, Escitalopram combined with psychotherapy, Escitalopram combined with rTMS, Escitalopram combined with sham rTMS
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
The US Food and Drug Administration(FDA) has only approved fluoxetine and escitalopram for the treatment of adolescent depression
Interpersonal Psychotherapy for AdolescentOther
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 psychotherapyOther
The subjects received adolescent interpersonal psychotherapy for adolescent(IPT-A) while taking medication
Escitalopram combined with rTMSOther
The subjects received Robotic navigational repetitive transcranial magnetic stimulation while taking medication
Escitalopram combined with sham rTMSDrug
The subjects received sham Robotic navigational repetitive transcranial magnetic stimulation while taking medication
| Study group | Role | What they receive |
|---|---|---|
| Simple Medication | Active comparator | Escitalopram alone treatment Receives: Drug: Escitalopram |
| Simple Psychotherapy | Active comparator | Simple interpersonal psychotherapy group Receives: Other: Interpersonal Psychotherapy for Adolescent |
| Medication combined with psychotherapy | Experimental | Medication combined with interpersonal psychotherapy Receives: Other: Escitalopram combined with psychotherapy |
| Medication combined with physical therapy group | Experimental | Medication combined with robotic navigational repetitive transcranial magnetic stimulation Receives: Other: Escitalopram combined with rTMS |
| Medication combined with sham physical therapy group | Sham comparator | Medication combined with sham robotic navigational repetitive transcranial magnetic stimulation Receives: Drug: Escitalopram combined with sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Child Depression Rating Scale-Revised
For clinical depression symptom assessment
Measured: Baseline, 2-week, 4-week, 8-week
Score of Beck Scale for Suicide Ideation
For the quantitative assessment of suicidal ideation
Measured: 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
Measured: 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
Measured: Baseline, 2-week, 8-week
Hypocretin
Hypocretin is a neurotransmitter that regulates wakefulness and appetite
Measured: 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
Measured: Baseline, 2-week, 8-week
Neuroimmune-related factors
Such as IL-lβ、IL-6、TNF-α
Measured: Baseline, 2-week, 8-week
Neurotrophic pathway related factors
Such as BDNF、VGF、TrkB、tPA
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline, 2-week, 8-week
Secondary outcomes (3)
Score of 24-item Hamilton Depression Rating Scale
For clinical depression symptom assessment
Measured: Baseline, 2-week, 4-week, 8-week
Ottawa Self-injury Questionnaire
To evaluate the situation of NSSI among adolescents
Measured: Baseline, 2-week, 4-week, 8-week
Score of Childhood Trauma Questionnaire
Used to assess traumatic experiences in childhood
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start31 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945342
- Sponsor's protocol ID
- IIT2023510
- Status last verified
- Mar 2024
- First submitted
- 5 May 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Application of Key Technologies for Early Identification, Risk Warning and Comprehensive Intervention of Adolescent Depression
- ClinicalTrials.gov ID
- NCT05945342
- Acronym / sponsor ID
- IIT2023510
- Conditions
- Depressive Disorder, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Simple Medication | Active comparator | Drug: EscitalopramEscitalopram alone treatment |
| Simple Psychotherapy | Active comparator | Other: Interpersonal Psychotherapy for AdolescentSimple interpersonal psychotherapy group |
| Medication combined with psychotherapy | Experimental | Other: Escitalopram combined with psychotherapyMedication combined with interpersonal psychotherapy |
| Medication combined with physical therapy group | Experimental | Other: Escitalopram combined with rTMSMedication combined with robotic navigational repetitive transcranial magnetic stimulation |
| Medication combined with sham physical therapy group | Sham comparator | Drug: Escitalopram combined with sham rTMSMedication combined with sham robotic navigational repetitive transcranial magnetic stimulation |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramThe US Food and Drug Administration(FDA) has only approved fluoxetine and escitalopram for the treatment of adolescent depression | Drug | Simple Medication |
| Interpersonal Psychotherapy for AdolescentInterpersonal 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. | Other | Simple Psychotherapy |
| Escitalopram combined with psychotherapyThe subjects received adolescent interpersonal psychotherapy for adolescent(IPT-A) while taking medication | Other | Medication combined with psychotherapy |
| Escitalopram combined with rTMSThe subjects received Robotic navigational repetitive transcranial magnetic stimulation while taking medication | Other | Medication combined with physical therapy group |
| Escitalopram combined with sham rTMSThe subjects received sham Robotic navigational repetitive transcranial magnetic stimulation while taking medication | Drug | Medication combined with sham physical therapy group |
Primary outcome
Score of Child Depression Rating Scale-Revised
Time frame: Baseline, 2-week, 4-week, 8-week
For clinical depression symptom assessment
Score of Beck Scale for Suicide Ideation
Time frame: Baseline, 2-week, 4-week, 8-week
For the quantitative assessment of suicidal ideation
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
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
Hypocretin
Time frame: Baseline, 2-week, 8-week
Hypocretin is a neurotransmitter that regulates wakefulness and appetite
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
Neuroimmune-related factors
Time frame: Baseline, 2-week, 8-week
Such as IL-lβ、IL-6、TNF-α
Neurotrophic pathway related factors
Time frame: Baseline, 2-week, 8-week
Such as BDNF、VGF、TrkB、tPA
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.
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
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
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.
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
3 secondary outcomes
Score of 24-item Hamilton Depression Rating Scale
Time frame: Baseline, 2-week, 4-week, 8-week
Ottawa Self-injury Questionnaire
Time frame: Baseline, 2-week, 4-week, 8-week
Score of Childhood Trauma Questionnaire
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram, Interpersonal Psychotherapy for Adolescent and Escitalopram combined with psychotherapy in people with Depressive Disorder and Adolescent, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang, Manli, M.D (13957162975 ext. 86, huangmanli@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Child Depression Rating Scale-Revised (time frame: Baseline, 2-week, 4-week, 8-week). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.