the Use of Antidepressants in Patients With Bipolar DepressionPhase 4NCT03148535
Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder
A Phase 4 study testing Lithium Carbonate and lithium carbonate combined with SSRI antidepressant treatment in people with the Use of Antidepressants in Patients With Bipolar Depression, run by Peking University at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- the Use of Antidepressants in Patients With Bipolar Depression
- What is being tested?
- Lithium Carbonate and lithium carbonate combined with SSRI antidepressant treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jun 2017to 1 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-55 years old, bipolar depression
Who cannot join
- other mental illness, serious somatic illnesses, MRI contradictions.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Institute of mental health, Peking University
Beijing, Beijing Municipality, 100191
Tianmei Si, PhD., 8610-82801960, si.tian-mei@163.com
Tianmei Si, PhD.
- Recruiting
Dalian No.7 People's Hospital
Dalian, Liaoning, 116000
Shoufu Xie, MD., 86-18441168381, shoufuxie@126.com
- Recruiting
Nanjing Brain Hospital
Nanjing, Jiangsu, 210000
Zhijian Yao, PhD., 86-13851580276, zhijianyao@163.com
- Recruiting
The first hospital of Hebei Province University
Shijiazhuang, Hebei, 050000
Xueyi Wang, Professor, 0311-85917290
Xueyi Wang
About this study
Official title: 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.
- Being tested
- Lithium Carbonate, lithium carbonate combined with SSRI antidepressant treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium CarbonateDrug
bipolar depression recieve lithium Carbonate treatment
lithium carbonate combined with SSRI antidepressant treatmentDrug
lithium carbonate combined with SSRI antidepressant treatment
| Study group | Role | What they receive |
|---|---|---|
| lithium carbonate | Experimental | recieve lithium carbonate Receives: Drug: Lithium Carbonate |
| lithium carbonate combined with SSRI antidepressant treatment | Experimental | recieve lithium carbonate combined with SSRI antidepressant treatment Receives: Drug: lithium carbonate combined with SSRI antidepressant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRSD reduction ratio
HRSD reduction ratio
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Use of Antidepressants in Patients With Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si Tianmei, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148535
- Sponsor's protocol ID
- 2016-1-4111
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Psychopharmacology Division Institute of Mental Health, Peking University
- ClinicalTrials.gov ID
- NCT03148535
- Acronym / sponsor ID
- 2016-1-4111
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lithium carbonate | Experimental | Drug: Lithium Carbonaterecieve lithium carbonate |
| lithium carbonate combined with SSRI antidepressant treatment | Experimental | Drug: lithium carbonate combined with SSRI antidepressant treatmentrecieve lithium carbonate combined with SSRI antidepressant treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 18-55 years old, bipolar depression
Key exclusion criteria (1 listed)
- other mental illness, serious somatic illnesses, MRI contradictions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithium Carbonatebipolar depression recieve lithium Carbonate treatment | Drug | lithium carbonate |
| lithium carbonate combined with SSRI antidepressant treatmentlithium carbonate combined with SSRI antidepressant treatment | Drug | lithium carbonate combined with SSRI antidepressant treatment |
Primary outcome
HRSD reduction ratio
Time frame: 8 weeks
HRSD reduction ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lithium Carbonate and lithium carbonate combined with SSRI antidepressant treatment in people with the Use of Antidepressants in Patients With Bipolar Depression, run by Peking University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-Tao Li, MD (010-62723742, ljt_102124@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRSD reduction ratio (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.