DepressionPhase 4DCMNCT01287494
Depression Care Management for Depressed Elders in China Primary Care
A Phase 4 study testing Sertraline in people with Depression, run by Zhejiang University at 1 site in China.
Trial summary
Using a randomized controlled design, the investigators will examine whether the DCM is an effective treatment for patients with late life depression in urban China. Our specific aims are: (1) to determine whether the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Jul 2014
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years old
- Community-dwelling residences
- Capable of independent communication
- Mini-Mental State Examination (MMSE) score ≥ 18
Who cannot join
- Incapable of giving written informed consent to this study
- Acute high suicide risk at baseline assessment
- Psychosis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Univeristy
Hangzhou, Zhejiang, 310028
Yang Cao, Master, 86-571-88981775, kyycy@zju.edu.cn
Baihua XU, PhD, 86-571-88273336, xubaihua501@126.com
About this study
Official title: Collaborative Care for Depressed Elders in China
Using a randomized controlled design, the investigators will examine whether the DCM is an effective treatment for patients with late life depression in urban China. Our specific aims are: (1) to determine whether the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms); and (2) to compare DCM with CAU with regard to a range of outcomes in other pertinent domains, both at the provider (e.g., improvements in knowledge/attitudes) and patient (e.g., functioning, satisfaction) levels. The study will take place in 16 primary care clinics (PCCs) randomly assigned to deliver either DCM or CAU (8 clinics each) to 320 patients (aged≥60 years) with major depression (20/clinic; n=160 in each treatment condition). In the DCM arm, PCPs will prescribe 16 weeks of antidepressant medication according to the TG protocol. CMs monitor the progress of treatment and side effects, educate patients/family, and facilitate communication between providers; psychiatrists will provide weekly group psychiatric consultation and CM supervision. Patients in both DCM and CAU arms will be assessed by clinical research coordinators at baseline, 4, 8, 12, 18, and 24 months. HDRS, MMSE, CAS, SF-12, Treatment Stigma and the Client Satisfaction Questionnaire will be used to assess patients' outcomes; and clinic practices, attitudes/knowledge, and satisfaction will be providers' outcomes.
Read the detailed description
- At the patient level: The investigator will gather information about age, gender, education, marital status, living conditions and satisfaction with their economic status, as well as systematic information on suicidal ideation,, psychopathology, medical health, cognitive function, quality of life and stigma and satisfaction for the treatment.
- At the provider level: the objective of research measures at the provider level is to gather social-demographic data such as age, gender, education, marital status, clinical experience among physicians in the participating PCCs as well as systematic information on their attitudes/knowledge regarding depression and clinical practices with the treatment guidelines.
- Conditions
- Depression
- Being tested
- Sertraline
- Keywords
- elderly, care management, primary care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
dosage form: Capsule dosage: 50-200mg/d frequency: once per day duration: 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Depression Care Management | Experimental | DCM Intervention for Depressed Elders in Primary Care
* Treatment guidelines (TG): Eight weeks treatment with Sertraline, another 8 weeks treatment augmentation with Bupropion if patients fail to respond in the initial trial, For more complicated cases, the transfer to psychiatrists is indicated.
* Care managers: Screening, Adherence support, psychoeducation and communication.
* Psychiatric Consultation Receives: Drug: Sertraline |
| Care as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms)
16 weeks treatment with Sertraline and following up 2 years
Measured: 16 weeks
Secondary outcomes (1)
compare DCM with CAU with regard to a range of outcomes in other pertinent domains, both at the provider (e.g., improvements in knowledge/attitudes) and patient (e.g., functioning, satisfaction) levels
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startAug 2010
- Primary completionFeb 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Investigators
- Ju Zhang, PhD, Study director, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287494
- Sponsor's protocol ID
- DCM in China
- Acronym
- DCM
- Status last verified
- Jan 2011
- First submitted
- 27 Jan 2011
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen S, Chiu H, Xu B, Ma Y, Jin T, Wu M, Conwell Y. Reliability and validity of the PHQ-9 for screening late-life depression in Chinese primary care. Int J Geriatr Psychiatry. 2010 Nov;25(11):1127-33. doi: 10.1002/gps.2442.
PubMed 20029795Chen S, Conwell Y, He J, Lu N, Wu J. Depression care management for adults older than 60 years in primary care clinics in urban China: a cluster-randomised trial. Lancet Psychiatry. 2015 Apr;2(4):332-9. doi: 10.1016/S2215-0366(15)00002-4. Epub 2015 Mar 31.
PubMed 26360086Chen S, Conwell Y, Xu B, Chiu H, Tu X, Ma Y. Depression care management for late-life depression in China primary care: protocol for a randomized controlled trial. Trials. 2011 May 13;12:121. doi: 10.1186/1745-6215-12-121.
PubMed 21569445
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for Depressed Elders in China
- ClinicalTrials.gov ID
- NCT01287494
- Acronym / sponsor ID
- DCM / DCM in China
- Conditions
- Depression
- Keywords
- elderly, care management, primary care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 1 Feb 2011 (estimated)
- 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.
Using a randomized controlled design, the investigators will examine whether the DCM is an effective treatment for patients with late life depression in urban China. Our specific aims are: (1) to determine whether the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms); and (2) to compare DCM with CAU with regard to a range of outcomes in other pertinent domains, both at the provider (e.g., improvements in knowledge/attitudes) and patient (e.g., functioning, satisfaction) levels. The study will take place in 16 primary care clinics (PCCs) randomly assigned to deliver either DCM or CAU (8 clinics each) to 320 patients (aged≥60 years) with major depression (20/clinic; n=160 in each treatment condition). In the DCM arm, PCPs will prescribe 16 weeks of antidepressant medication according to the TG protocol. CMs monitor the progress of treatment and side effects, educate patients/family, and facilitate communication between providers; psychiatrists will provide weekly group psychiatric consultation and CM supervision. Patients in both DCM and CAU arms will be assessed by clinical research coordinators at baseline, 4, 8, 12, 18, and 24 months. HDRS, MMSE, CAS, SF-12, Treatment Stigma and the Client Satisfaction Questionnaire will be used to assess patients' outcomes; and clinic practices, attitudes/knowledge, and satisfaction will be providers' outcomes.
Detailed description
- At the patient level: The investigator will gather information about age, gender, education, marital status, living conditions and satisfaction with their economic status, as well as systematic information on suicidal ideation,, psychopathology, medical health, cognitive function, quality of life and stigma and satisfaction for the treatment.
- At the provider level: the objective of research measures at the provider level is to gather social-demographic data such as age, gender, education, marital status, clinical experience among physicians in the participating PCCs as well as systematic information on their attitudes/knowledge regarding depression and clinical practices with the treatment guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depression Care Management | Experimental | Drug: SertralineDCM Intervention for Depressed Elders in Primary Care * Treatment guidelines (TG): Eight weeks treatment with Sertraline, another 8 weeks treatment augmentation with Bupropion if patients fail to respond in the initial trial, For more complicated cases, the transfer to psychiatrists is indicated. * Care managers: Screening, Adherence support, psychoeducation and communication. * Psychiatric Consultation |
| Care as Usual | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 60 years old
- Community-dwelling residences
- Capable of independent communication
- Mini-Mental State Examination (MMSE) score ≥ 18
Key exclusion criteria (3 listed)
- Incapable of giving written informed consent to this study
- Acute high suicide risk at baseline assessment
- Psychosis
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 |
|---|---|---|
| SertralineAlso: Zoloftdosage form: Capsule dosage: 50-200mg/d frequency: once per day duration: 16 weeks | Drug | Depression Care Management |
Primary outcome
the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms)
Time frame: 16 weeks
16 weeks treatment with Sertraline and following up 2 years
1 secondary outcome
compare DCM with CAU with regard to a range of outcomes in other pertinent domains, both at the provider (e.g., improvements in knowledge/attitudes) and patient (e.g., functioning, satisfaction) levels
Time frame: 28 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
- Background: PubMed 20029795Chen S, Chiu H, Xu B, Ma Y, Jin T, Wu M, Conwell Y. Reliability and validity of the PHQ-9 for screening late-life depression in Chinese primary care. Int J Geriatr Psychiatry. 2010 Nov;25(11):1127-33. doi: 10.1002/gps.2442.
- Derived from this study: PubMed 26360086Chen S, Conwell Y, He J, Lu N, Wu J. Depression care management for adults older than 60 years in primary care clinics in urban China: a cluster-randomised trial. Lancet Psychiatry. 2015 Apr;2(4):332-9. doi: 10.1016/S2215-0366(15)00002-4. Epub 2015 Mar 31.
- Derived from this study: PubMed 21569445Chen S, Conwell Y, Xu B, Chiu H, Tu X, Ma Y. Depression care management for late-life depression in China primary care: protocol for a randomized controlled trial. Trials. 2011 May 13;12:121. doi: 10.1186/1745-6215-12-121.
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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.
Ju Zhang, PhD study director
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sertraline in people with Depression, run by Zhejiang University at 1 site 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 4 inclusion and 3 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 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Shulin Chen, MD&PhD (86-571-88273337, csl@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287494, which also lists 3 linked publications.
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 1 Feb 2011.