NCT04684277

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

December 21, 2020

Last Update Submit

September 21, 2021

Conditions

DepressionMedication Adherence

Outcome Measures

Primary Outcomes (2)

  • HAMD17 reduction ratio

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

    3 months

  • recurrence rate

    The difference of recurrence rate between the two groups was compared

    12 months

Study Arms (2)

antidepressant treatment

EXPERIMENTAL

recieve antidepressant treatment

Drug: antidepressant treatment

antidepressant treatment combined with Internet-based interventions

EXPERIMENTAL

recieve antidepressant treatment combined with Internet-based interventions

Other: antidepressant treatment combined with Internet-based interventions

Interventions

antidepressant treatmentDRUG

depression recieve antidepressant treatment

antidepressant treatment
antidepressant treatment combined with Internet-based interventionsOTHER

depression recieve antidepressant treatment combined with Internet-based interventions

antidepressant treatment combined with Internet-based interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • other mental illnesses, serious somatic illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunai Su

Beijing, China

RECRUITING

MeSH Terms

Conditions

DepressionMedication Adherence

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Tianmei Si, PhD

    Institute of mental health, Peking University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunai Su, MD

CONTACT

8610-62352880suyunai@163.com

Jitao Li, MD

CONTACT

8610-82801960ljt_102124@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 24, 2020

Study Start

September 1, 2021

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)