Depression Clinical Trial
Official title:
A Prospective, Randomized, Multicenter, Placebo-controlled Clinical Trial Evaluating the Efficacy and Safety of Adjuvant Intervention Software for Depression in Patients With Mild to Moderate Depression
Verified date | September 2022 |
Source | Adai Technology (Beijing) Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main purpose of this clinical trial is to evaluate the clinical efficacy and safety of adjuvant intervention therapy software for depression in patients with mild to moderate depression
Status | Not yet recruiting |
Enrollment | 456 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Patients voluntarily participate in the trial and sign the informed consent; 2. Age 18-60 years old (including 18 years old and 60 years old), gender is not limited; 3. The clinical diagnosis complies with the diagnostic criteria for depression in the "Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, DSM-5" (through the International Neuropsychiatry Brief Interview Questionnaire (Mini- International Neuropsychiatric Interview, M.I.N.I.) confirming the diagnosis) without psychotic symptoms; 4. Patients with Montgomery Depression Rating Scale (MADRS) score greater than or equal to 12 and less than 30 at screening; 5. Patients who have not received antidepressant systemic treatment within 2 weeks before screening, and who can maintain no need for antidepressant treatment during the trial period as assessed by the research doctor; or take serotonin reuptake stably for at least 6 weeks before screening Inhibitor (Selective Serotonin Reuptake Inhibitor, SSRI) class, or serotonin and norepinephrine reuptake dual inhibitor (Serotonin-Norepinephrine Reuptake Inhibitor, SNRI) class, or noradrenergic and specific serotonergic Antidepressants (Noradrenergic and Specific Serotonergic Antidepressants, NaSSA) antidepressants, and the medication compliance is 80%-120% and the drug dose adjustment is less than 20%, and the antidepressant treatment can be maintained during the trial period as assessed by the clinician patients on the original treatment regimen; 6. Patients with primary school education or above, who can understand the content of the scale and can use smart phones proficiently. Exclusion Criteria: 1. Patients whose clinical diagnosis meets the diagnostic criteria for other mental disorders except depression in DSM-5 (diagnosis confirmed by M.I.N.I.); 2. Patients with refractory depression (those who have been treated with 2 or more antidepressants with different chemical structures in the past or currently, and who have been treated with a sufficient dose and a full course of treatment (at least 4 weeks according to the maximum dose in the instructions) are ineffective); 3. Patients with a history of alcohol and drug dependence; 4. Pregnant or breastfeeding female patients, or male or female patients with reproductive plans during clinical trials; 5. Those with 10. Suicidal ideation score of MADRS score greater than or equal to 4 points, that is, those with severe suicidal ideation or suicide attempt; 6. Patients received other antidepressant treatment methods within 3 months before enrollment, including traditional Chinese medicine, modified electroconvulsive therapy (MECT), transcranial magnetic stimulation, biofeedback therapy, phototherapy, acupuncture and other physical therapy and system psychology treat; 7. Severe physical disease, severe liver, renal insufficiency and thyroid disease (Alanine Aminotransferase (ALT), or Aspartate Aminotransferase (AST) exceeds the upper limit of normal twice at screening, or total Bilirubin (Total Bilirubin, TBIL) exceeds 1.5 times the upper limit of normal; Creatinine (CR) exceeds 1.2 times the upper limit of normal; Thyroid Stimulating Hormone (TSH) exceeds the upper limit of normal), or as judged by the investigator Patients with other diseases who are not suitable for inclusion in this trial; upon the judgment of the investigator, a re-examination of non-compliant laboratory tests is allowed, but the re-examination must be completed within the screening period; 8. Patients who clearly express their unwillingness to participate in psychotherapy, or who think that psychotherapy is ineffective; 9. Patients who have participated in or are participating in drug clinical trials within 3 months before screening, or patients who have participated in or are participating in other device clinical trials within 1 month before screening; 10. Other conditions judged by the investigator to be unsuitable for inclusion. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Adai Technology (Beijing) Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery-Asberg Depression Rating Scale | Montgomery-Asberg Depression Rating Scale.The maximum value of the Montgomery-Asberg Depression Rating Scale is 60, and the minimum value of the Montgomery-Asberg Depression Rating Scale is 0.Higher scores mean a worse outcome. | 56 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |