Guidance Model of Standardized Treatment of Antidepressan... | NCT03148535

Studies
Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder

NCT03148535

Sponsor

Peking University

Status

Unknown status

Last Update Posted

May 11, 2017Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

the Use of Antidepressants in Patients With Bipolar Depression

Interventions

Lithium Carbonate
lithium carbonate combined with SSRI antidepressant treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Estimated

Primary Completion Date

Dec 1, 2018Estimated

Completion Date

Dec 1, 2018Estimated

First Submitted Date

May 9, 2017

First Submission Date that Met QC Criteria

May 9, 2017

First Posted Date

May 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2017

Last Update Posted Date

May 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Si Tianmei, Clinical Psychopharmacology Division Institute of Mental Health, Peking UniversityPrincipal Investigator

Lead Sponsor

Peking UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lithium carbonate	Experimental	recieve lithium carbonate	Drug: Lithium Carbonate
lithium carbonate combined with SSRI antidepressant treatment	Experimental	recieve lithium carbonate combined with SSRI antidepressant treatment	Drug: lithium carbonate combined with SSRI antidepressant treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lithium Carbonate	Drug	bipolar depression recieve lithium Carbonate treatment	lithium carbonate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HRSD reduction ratio	HRSD reduction ratio	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-55 years old, bipolar depression

Exclusion Criteria:

other mental illness, serious somatic illnesses, MRI contradictions.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ji-Tao Li, MD	Contact	010-62723742		ljt_102124@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of mental health, Peking University	Recruiting	Beijing	Beijing Municipality	100191	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016651	Lithium Carbonate

Ancestor Terms

ID	Term
D002254	Carbonates
D000468	Alkalies
D007287	Inorganic Chemicals
D002255	Carbonic Acid

Browse Leaves

Not provided

Browse Branches

Not provided