- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03148535
Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder
May 9, 2017 updated by: Si Tianmei, Peking University
Clinical Psychopharmacology Division Institute of Mental Health, Peking University
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Recruiting
- Institute of Mental Health, Peking University
-
Contact:
- Tianmei Si, PhD.
- Phone Number: 8610-82801960
- Email: si.tian-mei@163.com
-
Principal Investigator:
- Tianmei Si, PhD.
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050000
- Recruiting
- The first hospital of Hebei Province University
-
Contact:
- Xueyi Wang, Professor
- Phone Number: 0311-85917290
-
Sub-Investigator:
- Xueyi Wang
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210000
- Recruiting
- Nanjing Brain Hospital
-
Contact:
- Zhijian Yao, PhD.
- Phone Number: 86-13851580276
- Email: zhijianyao@163.com
-
-
Liaoning
-
Dalian, Liaoning, China, 116000
- Recruiting
- Dalian No.7 People's Hospital
-
Contact:
- Shoufu Xie, MD.
- Phone Number: 86-18441168381
- Email: shoufuxie@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18-55 years old, bipolar depression
Exclusion Criteria:
- other mental illness, serious somatic illnesses, MRI contradictions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: lithium carbonate
recieve lithium carbonate
|
bipolar depression recieve lithium Carbonate treatment
|
Experimental: lithium carbonate combined with SSRI antidepressant treatment
recieve lithium carbonate combined with SSRI antidepressant treatment
|
lithium carbonate combined with SSRI antidepressant treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HRSD reduction ratio
Time Frame: 8 weeks
|
HRSD reduction ratio
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2017
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
May 9, 2017
First Submitted That Met QC Criteria
May 9, 2017
First Posted (Actual)
May 11, 2017
Study Record Updates
Last Update Posted (Actual)
May 11, 2017
Last Update Submitted That Met QC Criteria
May 9, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-1-4111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on the Use of Antidepressants in Patients With Bipolar Depression
-
Chun PanUnknownEvaluate the Correlation Between the Level of Mitochondrial DNA in Plasma and the Prognosis of the Patients With ARDS.China
-
Copenhagen Trial Unit, Center for Clinical Intervention...The Info Trial Group; Charlotte Behnke; Pia Caspersen; Dorte Fischer; Rolf I. Hansen and other collaboratorsCompletedAmbulatory Patients in the Dep. of Medical Gastroenterology | Ambulatory Patients in the Dep. of Gynecology | Ambulatory Patients in the Dep. of Orthopedic Surgery | Ambulatory Patients in the Dep. of UrologyDenmark
-
H. Lundbeck A/STerminatedDepression in Patients With Bipolar DisorderAustria, Philippines, Australia, Belgium, Bulgaria, Canada, France, Germany, Korea, Republic of, Lithuania, Malaysia, Poland, Romania, Slovakia, Sweden, Taiwan, Ukraine, United Kingdom
-
Yonsei UniversityWithdrawnPatients in the Treatment of Subjects With All-comer Who Are to Undergo PCI
-
CerbaXpertRecruitingEvaluate the Physiological Stability of NIS4 Biomarker Between the Fed and Fasting State in Patients With the Target Condition (NAFLD)France
-
Bursa Yüksek İhtisas Education and Research HospitalCompletedThe Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee PainTurkey
-
Assistance Publique - Hôpitaux de ParisCompletedPatients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch DonorFrance
-
Shanghai General Hospital, Shanghai Jiao Tong University...Not yet recruitingTo Evaluate the Safety and Tolerability of Intravitreal Injection of LX109 in Patients With nAMD
-
Zhongshan Bo Ai HospitalCompletedThe Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group; | At the Same Time, the Investigators Continuedly Collect Cases to October 2012, and Totally Collected 579 Patients With PCOS Altogether; | 534... and other conditionsChina
-
Stefania CostiArcispedale Santa Maria Nuova-IRCCSCompletedComplex Patients: Patients With High Level of Complexity Regardless of the Pathology of Origin
Clinical Trials on Lithium Carbonate
-
Northwestern UniversityCompletedBipolar DisorderUnited States
-
New York State Psychiatric InstituteNational Institute on Aging (NIA)CompletedPsychosis | Alzheimer's Disease | AgitationUnited States
-
Shanghai Mental Health CenterUnknown
-
The University of Hong KongChina Spinal Cord Injury NetworkCompletedSpinal Cord InjuriesChina
-
University of Wisconsin, MadisonTerminatedMedullary Thyroid CancerUnited States
-
Brigham and Women's HospitalRecruitingDepression | Bipolar Disorder | Bipolar Depression | Major Depressive Episode | Bipolar I Depression | Bipolar II DepressionUnited States
-
University of Maryland, BaltimoreCompletedOsteoporosis PseudogliomaUnited States
-
University of OxfordCompleted
-
New York State Psychiatric InstituteCompletedBipolar Disorder | Major Depressive DisorderUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedPrimary Myelofibrosis | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Chronic Myelomonocytic Leukemia | Recurrent Adult Acute Myeloid Leukemia | Juvenile Myelomonocytic Leukemia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal... and other conditionsUnited States