Back to resultsGuidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder
Primary Purpose
the Use of Antidepressants in Patients With Bipolar Depression
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lithium Carbonate
lithium carbonate combined with SSRI antidepressant treatment
Sponsored by
About this trial
This is an interventional treatment trial for the Use of Antidepressants in Patients With Bipolar Depression
Eligibility Criteria
Inclusion Criteria:
- age 18-55 years old, bipolar depression
Exclusion Criteria:
- other mental illness, serious somatic illnesses, MRI contradictions.
Sites / Locations
- Institute of mental health, Peking UniversityRecruiting
- The first hospital of Hebei Province UniversityRecruiting
- Nanjing Brain HospitalRecruiting
- Dalian No.7 People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
lithium carbonate
lithium carbonate combined with SSRI antidepressant treatment
Arm Description
recieve lithium carbonate
recieve lithium carbonate combined with SSRI antidepressant treatment
Outcomes
Primary Outcome Measures
HRSD reduction ratio
HRSD reduction ratio
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03148535
Brief Title
Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder
Official Title
Clinical Psychopharmacology Division Institute of Mental Health, Peking University
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (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
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Use of Antidepressants in Patients With Bipolar Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lithium carbonate
Arm Type
Experimental
Arm Description
recieve lithium carbonate
Arm Title
lithium carbonate combined with SSRI antidepressant treatment
Arm Type
Experimental
Arm Description
recieve lithium carbonate combined with SSRI antidepressant treatment
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate
Intervention Description
bipolar depression recieve lithium Carbonate treatment
Intervention Type
Drug
Intervention Name(s)
lithium carbonate combined with SSRI antidepressant treatment
Intervention Description
lithium carbonate combined with SSRI antidepressant treatment
Primary Outcome Measure Information:
Title
HRSD reduction ratio
Description
HRSD reduction ratio
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18-55 years old, bipolar depression
Exclusion Criteria:
other mental illness, serious somatic illnesses, MRI contradictions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Tao Li, MD
Phone
010-62723742
Email
ljt_102124@163.com
Facility Information:
Facility Name
Institute of mental health, Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianmei Si, PhD.
Phone
8610-82801960
Email
si.tian-mei@163.com
First Name & Middle Initial & Last Name & Degree
Tianmei Si, PhD.
Facility Name
The first hospital of Hebei Province University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueyi Wang, Professor
Phone
0311-85917290
First Name & Middle Initial & Last Name & Degree
Xueyi Wang
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhijian Yao, PhD.
Phone
86-13851580276
Email
zhijianyao@163.com
Facility Name
Dalian No.7 People's Hospital
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoufu Xie, MD.
Phone
86-18441168381
Email
shoufuxie@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder
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