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Internet-Based Interventions for MDD

Primary Purpose

Depression, Medication Adherence

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
antidepressant treatment
antidepressant treatment combined with Internet-based interventions
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age 18-65 years old, acute (HAMD17 > 17) and remission (HAMD17 < 8) depression

Exclusion Criteria:

  • other mental illnesses, serious somatic illnesses

Sites / Locations

  • Yunai SuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

antidepressant treatment

antidepressant treatment combined with Internet-based interventions

Arm Description

recieve antidepressant treatment

recieve antidepressant treatment combined with Internet-based interventions

Outcomes

Primary Outcome Measures

HAMD17 reduction ratio
The difference of HAMD17 reduction ratio between the two groups was compared
recurrence rate
The difference of recurrence rate between the two groups was compared

Secondary Outcome Measures

Full Information

First Posted
December 21, 2020
Last Updated
September 21, 2021
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT04684277
Brief Title
Internet-Based Interventions for MDD
Official Title
Effectiveness of Internet-Based Interventions for Treatment Compliance and Outcomes of Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Medication Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
antidepressant treatment
Arm Type
Experimental
Arm Description
recieve antidepressant treatment
Arm Title
antidepressant treatment combined with Internet-based interventions
Arm Type
Experimental
Arm Description
recieve antidepressant treatment combined with Internet-based interventions
Intervention Type
Drug
Intervention Name(s)
antidepressant treatment
Intervention Description
depression recieve antidepressant treatment
Intervention Type
Other
Intervention Name(s)
antidepressant treatment combined with Internet-based interventions
Intervention Description
depression recieve antidepressant treatment combined with Internet-based interventions
Primary Outcome Measure Information:
Title
HAMD17 reduction ratio
Description
The difference of HAMD17 reduction ratio between the two groups was compared
Time Frame
3 months
Title
recurrence rate
Description
The difference of recurrence rate between the two groups was compared
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 18-65 years old, acute (HAMD17 > 17) and remission (HAMD17 < 8) depression Exclusion Criteria: other mental illnesses, serious somatic illnesses
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunai Su, MD
Phone
8610-62352880
Email
suyunai@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jitao Li, MD
Phone
8610-82801960
Email
ljt_102124@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tianmei Si, PhD
Organizational Affiliation
Institute of mental health, Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yunai Su
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunai Su

12. IPD Sharing Statement

Plan to Share IPD
No

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Internet-Based Interventions for MDD

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