Major Depressive DisorderPhase 4NCT01460212
Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder
A Phase 4 study testing SSRI antidepressants and Cognitive-Behavior Therapy in people with Major Depressive Disorder, run by Nanjing Medical University at 1 site in China.
Trial summary
Study hypothesis: psychotherapy and SSRI treatment effect in different brain way: psychotherapy in "up to down" way and SSRI in "down to up" way. The investigators will explore this hypothesis in major depressive disorder outpatients with Magnetic Resonance Imaging analysis in this study. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SSRI antidepressants and Cognitive-Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Oct 2015
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- meet SCID -Ⅰ/P major depressive disorder diagnosis;
- Right handedness;
- good visual acuity.
Who cannot join
- neurological disease ;
- serious physical illness (e.g. heart, lung, liver, kidney or blood system disease);
- with other mental disorder;
- psychotic symptoms
- personality disorders;
- pregnancy;
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- suicidal risk;
- treatment by antidepressants or other psychotropic medications within 6 months prior to the start of the trial;
- with contraindication for MRI
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Brain Hospital
Nanjing, Jiangsu, 210029
Chun Wang
About this study
Study hypothesis: psychotherapy and SSRI treatment effect in different brain way: psychotherapy in "up to down" way and SSRI in "down to up" way. The investigators will explore this hypothesis in major depressive disorder outpatients with Magnetic Resonance Imaging analysis in this study. Patients in different groups will be treated by psychotherapy or SSRI treatment. They will all be checked with Magnetic Resonance Imaging pro and after 12 weeks of treatment.
Read the detailed description
Patients meeting the inclusion criteria undergo an examination that included a diagnostic interview, vision test, and psychophysiological measures. Participants then undergo the baseline fMRI scan within 48 hours, after that, they will receive psychotherapy or SSRI treatment.and returned the scan once they completed the therapy.
- Conditions
- Major Depressive Disorder
- Being tested
- SSRI antidepressants, Cognitive-Behavior Therapy
- Keywords
- Cognitive-Behavior Therapy, Magnetic Resonance Imaging, major depressive disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSRI antidepressantsDrug
Also called fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa)
SSRI antidepressants are Selective serotonin reuptake inhibitors. They include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa) ;escitalopram (Lexapro) and fluvoxamine (Luvox). It will be chosen according to special condition of every patient.
Cognitive-Behavior TherapyBehavioural
Also called cognitive behavioural therapy（CBT）
The essence of CBT is a learning process through which an appropriate pattern in cognitive and behavioral could be learn and stored as memory
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavior Therapy group | Experimental | treatment with Cognitive-Behavior Therapy Receives: Behavioral: Cognitive-Behavior Therapy |
| SSRI antidepressants | Active comparator | treatment by SSRI antidepressant Receives: Drug: SSRI antidepressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAMD)
The 24-item version of the Hamilton Rating Scale for Depression (HAMD; Hamilton, 1960) will be used for measuring severity of depressive symptoms. Minimum and maximum possible values are respectively 0 and 78. Lower scores show more mild depression.
Measured: an expected average of 6 months
Secondary outcomes (1)
Magnetic Resonance Imaging
Measured: an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2014 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Nanjing Medical 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Wang, Nanjing Medical University
- Investigators
- Chun Wang, doctor, Principal investigator, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460212
- Sponsor's protocol ID
- QYK09184
- Status last verified
- Sep 2014
- First submitted
- 24 Oct 2011
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01460212
- Acronym / sponsor ID
- QYK09184
- Conditions
- Major Depressive Disorder
- Keywords
- Cognitive-Behavior Therapy, Magnetic Resonance Imaging, major depressive disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 26 Oct 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.
Study hypothesis: psychotherapy and SSRI treatment effect in different brain way: psychotherapy in "up to down" way and SSRI in "down to up" way. The investigators will explore this hypothesis in major depressive disorder outpatients with Magnetic Resonance Imaging analysis in this study. Patients in different groups will be treated by psychotherapy or SSRI treatment. They will all be checked with Magnetic Resonance Imaging pro and after 12 weeks of treatment.
Detailed description
Patients meeting the inclusion criteria undergo an examination that included a diagnostic interview, vision test, and psychophysiological measures. Participants then undergo the baseline fMRI scan within 48 hours, after that, they will receive psychotherapy or SSRI treatment.and returned the scan once they completed the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavior Therapy group | Experimental | Behavioral: Cognitive-Behavior Therapytreatment with Cognitive-Behavior Therapy |
| SSRI antidepressants | Active comparator | Drug: SSRI antidepressantstreatment by SSRI antidepressant |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- meet SCID -Ⅰ/P major depressive disorder diagnosis;
- Right handedness;
- good visual acuity.
Key exclusion criteria (9 listed)
- neurological disease ;
- serious physical illness (e.g. heart, lung, liver, kidney or blood system disease);
- with other mental disorder;
- psychotic symptoms
- personality disorders;
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 |
|---|---|---|
| SSRI antidepressantsAlso: fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa)SSRI antidepressants are Selective serotonin reuptake inhibitors. They include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa) ;escitalopram (Lexapro) and fluvoxamine (Luvox). It will be chosen according to special condition of every patient. | Drug | SSRI antidepressants |
| Cognitive-Behavior TherapyAlso: cognitive behavioural therapy（CBT）The essence of CBT is a learning process through which an appropriate pattern in cognitive and behavioral could be learn and stored as memory | Behavioural | Cognitive-Behavior Therapy group |
Primary outcome
Hamilton Rating Scale for Depression (HAMD)
Time frame: an expected average of 6 months
The 24-item version of the Hamilton Rating Scale for Depression (HAMD; Hamilton, 1960) will be used for measuring severity of depressive symptoms. Minimum and maximum possible values are respectively 0 and 78. Lower scores show more mild depression.
1 secondary outcome
Magnetic Resonance Imaging
Time frame: an expected average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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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.
Chun Wang, doctor principal investigator
Nanjing Medical 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 SSRI antidepressants and Cognitive-Behavior Therapy in people with Major Depressive Disorder, run by Nanjing Medical 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 3 inclusion and 9 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 25 Sep 2014. 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 Chun Wang, doctor (86 15850566376, fm51109@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (HAMD) (time frame: an expected average of 6 months). 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 25 Sep 2014.