DepressionNCT04684277
Internet-Based Interventions for MDD
A study testing antidepressant treatment and antidepressant treatment combined with Internet-based interventions in people with Depression and Medication Adherence, run by Peking University at 1 site in China.
Trial summary
The acute and remission depression patients of 18-65 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological and medication adherence data was collected. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Medication Adherence
- What is being tested?
- antidepressant treatment and antidepressant treatment combined with Internet-based interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Jun 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-65 years old, acute (HAMD17 > 17) and remission (HAMD17 < 8) depression
Who cannot join
- other mental illnesses, serious somatic illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Internet-Based Interventions for Treatment Compliance and Outcomes of Major Depressive Disorder
The acute and remission depression patients of 18-65 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological and medication adherence data was collected. After the completion of the baseline assessment and examination, the patients were given antidepressant treatment or antidepressant treatment combined with Internet-based interventions. Clinical evaluation was performed at 1, 3 months (acute patients) and 6, 12 months (remission patients) after treatment, including the medication adherence, therapeutic efficacy, recurrence rate and functional rehabilitation. Through above work, this research is expected to provide clinicians with a set of Internet generalized technologies to improve the compliance and clinical outcomes of patients with depression, and to provide patients with treatment and management of the entire disease cycle.
- Conditions
- Depression, Medication Adherence
- Being tested
- antidepressant treatment, antidepressant treatment combined with Internet-based interventions
- Medical subject headings
- Depression, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antidepressant treatmentDrug
depression recieve antidepressant treatment
antidepressant treatment combined with Internet-based interventionsOther
depression recieve antidepressant treatment combined with Internet-based interventions
| Study group | Role | What they receive |
|---|---|---|
| antidepressant treatment | Experimental | recieve antidepressant treatment Receives: Drug: antidepressant treatment |
| antidepressant treatment combined with Internet-based interventions | Experimental | recieve antidepressant treatment combined with Internet-based interventions Receives: Other: antidepressant treatment combined with Internet-based interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMD17 reduction ratio
The difference of HAMD17 reduction ratio between the two groups was compared
Measured: 3 months
recurrence rate
The difference of recurrence rate between the two groups was compared
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Sep 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si Tianmei, Peking University
- Investigators
- Tianmei Si, PhD, Principal investigator, Institute of mental health, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684277
- Sponsor's protocol ID
- SF2020-2-4113
- Status last verified
- Sep 2021
- First submitted
- 21 Dec 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Internet-Based Interventions for Treatment Compliance and Outcomes of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04684277
- Acronym / sponsor ID
- SF2020-2-4113
- Conditions
- Depression, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 24 Dec 2020 (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.
The acute and remission depression patients of 18-65 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological and medication adherence data was collected. After the completion of the baseline assessment and examination, the patients were given antidepressant treatment or antidepressant treatment combined with Internet-based interventions. Clinical evaluation was performed at 1, 3 months (acute patients) and 6, 12 months (remission patients) after treatment, including the medication adherence, therapeutic efficacy, recurrence rate and functional rehabilitation. Through above work, this research is expected to provide clinicians with a set of Internet generalized technologies to improve the compliance and clinical outcomes of patients with depression, and to provide patients with treatment and management of the entire disease cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antidepressant treatment | Experimental | Drug: antidepressant treatmentrecieve antidepressant treatment |
| antidepressant treatment combined with Internet-based interventions | Experimental | Other: antidepressant treatment combined with Internet-based interventionsrecieve antidepressant treatment combined with Internet-based interventions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 18-65 years old, acute (HAMD17 > 17) and remission (HAMD17 < 8) depression
Key exclusion criteria (1 listed)
- other mental illnesses, serious somatic illnesses
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 |
|---|---|---|
| antidepressant treatmentdepression recieve antidepressant treatment | Drug | antidepressant treatment |
| antidepressant treatment combined with Internet-based interventionsdepression recieve antidepressant treatment combined with Internet-based interventions | Other | antidepressant treatment combined with Internet-based interventions |
Primary outcome
HAMD17 reduction ratio
Time frame: 3 months
The difference of HAMD17 reduction ratio between the two groups was compared
recurrence rate
Time frame: 12 months
The difference of recurrence rate between the two groups was compared
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Tianmei Si, PhD principal investigator
Institute of mental health, Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antidepressant treatment and antidepressant treatment combined with Internet-based interventions in people with Depression and Medication Adherence, run by Peking 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 1 inclusion and 1 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 Sep 2021. 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. 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 Yunai Su, MD (8610-62352880, suyunai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAMD17 reduction ratio (time frame: 3 months). The study lists 2 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 Sep 2021.