Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder
Clinical Psychopharmacology Division Institute of Mental Health, Peking University
1 other identifier
interventional
100
1 country
4
Brief Summary
The bipolar depression patients of 18-55 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological, neurobiological and genetic data was collected. After the completion of the baseline assessment and examination, the patients were given lithium carbonate or lithium carbonate combined with SSRI antidepressant treatment. Clinical evaluation was performed at 2 and 8 weeks after treatment, including the therapeutic efficacy and adverse drug reactions, and monitoring of serum lithium concentration. The patients further receive the fMRI scans after treatment for 8 weeks. Through above work, this study aimed to provide some guidance for the use of antidepressants in patients with bipolar depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2017
4 active sites
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
May 9, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 11, 2017
May 1, 2017
1.5 years
May 9, 2017
May 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HRSD reduction ratio
HRSD reduction ratio
8 weeks
Study Arms (2)
lithium carbonate
EXPERIMENTALrecieve lithium carbonate
lithium carbonate combined with SSRI antidepressant treatment
EXPERIMENTALrecieve lithium carbonate combined with SSRI antidepressant treatment
Interventions
lithium carbonate combined with SSRI antidepressant treatment
Eligibility Criteria
You may qualify if:
- age 18-55 years old, bipolar depression
You may not qualify if:
- other mental illness, serious somatic illnesses, MRI contradictions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Institute of mental health, Peking University
Beijing, Beijing Municipality, 100191, China
The first hospital of Hebei Province University
Shijiazhuang, Hebei, 050000, China
Nanjing Brain Hospital
Nanjing, Jiangsu, 210000, China
Dalian No.7 People's Hospital
Dalian, Liaoning, 116000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Psychopharmacology Division Institute of Mental Health
Study Record Dates
First Submitted
May 9, 2017
First Posted
May 11, 2017
Study Start
June 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
May 11, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share