Bipolar DepressionPhase 4NCT01213121
Neurophysiologic Changes in Patients With Bipolar Depression
A Phase 4 study testing Quetiapine in people with Bipolar Depression, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
To examine differences in neurophysiologic parameters between unmedicated patients with bipolar depression and healthy controls To examine within-subject changes in neurophysiologic parameters in patients with bipolar depression treated with quetiapine Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Quetiapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- DSM-IV bipolar disorder I or II
- Depressive phase
- Drug-naive or drug-free
Who cannot join
- Serious medical or neurological conditions
- DSM-IV substance-related disorders (within 12 months prior to participation)
- Mentally retarded
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Neuropsychiatry, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Jae Seung Chang, M.D., Ph.D., 82-31-787-7437, cjs0107@snu.ac.kr
Ji Sun Kim, M.D., 82-10-9933-1286, ideal91@hanmail.net
About this study
Official title: Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression
- To examine differences in neurophysiologic parameters between unmedicated patients with bipolar depression and healthy controls
- To examine within-subject changes in neurophysiologic parameters in patients with bipolar depression treated with quetiapine
Read the detailed description
- Alterations of neurophysiologic regulation has been suggested in patients with major depressive disorder or bipolar disorders
- Depressive phase of bipolar disorder shows multi-faceted characteristics different from unipolar depression
- Quetiapine is an atypical antipsychotic licensed for treatment of bipolar depression
- The aim of this study is to investigate the pattern of neurophysiologic dysregulation in bipolar depression and its changes induced by quetiapine treatment
- Conditions
- Bipolar Depression
- Being tested
- Quetiapine
- Keywords
- bipolar depression, heart rate variability, cardio-respiratory coupling, electroencephalography
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Also called Seroquel
oral tablet/25-600mg per day/once a day/six weeks
| Study group | Role | What they receive |
|---|---|---|
| bipolar depression | Experimental | unmedicated patients with bipolar depression receiving quetiapine treatment Receives: Drug: Quetiapine |
| Control | No intervention | healthy controls matched for age, gender, and body mass index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
heart rate variability parameters of time/frequency/complexity domains
Measured: Six weeks
Secondary outcomes (4)
Cardio-Respiratory Coupling
integrative parameters of interaction between neurocardiac dynamics and respiratory rhythm
Measured: Six weeks
Electroencephalographic Changes
Electrical brain activities measured by quantitative electroencephalography
Measured: Six weeks
Severity of Mood Symptoms
- Hamilton Depression Rating Scale
- Bipolar Depression Rating Scale
- Young Mania Rating Scale
- Difficulties in Emotion Regulation Scale
- Emotion Regulation Questionnaire
Measured: Six weeks
Severity of Extrapyramidal Symptom Scale
Drug-Induced Extrapyramidal Symptom Scale
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2014 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Seung Chang, Seoul National University Bundang Hospital
- Investigators
- Jae Seung Chang, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213121
- Sponsor's protocol ID
- SNUBH 11-2010-040
- Status last verified
- Nov 2013
- First submitted
- 30 Sep 2010
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berger S, Boettger MK, Tancer M, Guinjoan SM, Yeragani VK, Bar KJ. Reduced cardio-respiratory coupling indicates suppression of vagal activity in healthy relatives of patients with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Mar 17;34(2):406-11. doi: 10.1016/j.pnpbp.2010.01.009. Epub 2010 Jan 18.
PubMed 20083149Bar KJ, Schuhmacher A, Hofels S, Schulz S, Voss A, Yeragani VK, Maier W, Zobel A. Reduced cardio-respiratory coupling after treatment with nortriptyline in contrast to S-citalopram. J Affect Disord. 2010 Dec;127(1-3):266-73. doi: 10.1016/j.jad.2010.05.010. Epub 2010 Jun 9.
PubMed 20538342Chang JS, Yoo CS, Yi SH, Hong KH, Oh HS, Hwang JY, Kim SG, Ahn YM, Kim YS. Differential pattern of heart rate variability in patients with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Aug 31;33(6):991-5. doi: 10.1016/j.pnpbp.2009.05.004. Epub 2009 May 7.
PubMed 19427888Kemp AH, Quintana DS, Gray MA, Felmingham KL, Brown K, Gatt JM. Impact of depression and antidepressant treatment on heart rate variability: a review and meta-analysis. Biol Psychiatry. 2010 Jun 1;67(11):1067-74. doi: 10.1016/j.biopsych.2009.12.012. Epub 2010 Feb 6.
PubMed 20138254Kemp AH, Gray MA, Silberstein RB, Armstrong SM, Nathan PJ. Augmentation of serotonin enhances pleasant and suppresses unpleasant cortical electrophysiological responses to visual emotional stimuli in humans. Neuroimage. 2004 Jul;22(3):1084-96. doi: 10.1016/j.neuroimage.2004.03.022.
PubMed 15219580
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression
- ClinicalTrials.gov ID
- NCT01213121
- Acronym / sponsor ID
- SNUBH 11-2010-040
- Conditions
- Bipolar Depression
- Keywords
- bipolar depression, heart rate variability, cardio-respiratory coupling, electroencephalography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 1 Oct 2010 (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.
- To examine differences in neurophysiologic parameters between unmedicated patients with bipolar depression and healthy controls
- To examine within-subject changes in neurophysiologic parameters in patients with bipolar depression treated with quetiapine
Detailed description
- Alterations of neurophysiologic regulation has been suggested in patients with major depressive disorder or bipolar disorders
- Depressive phase of bipolar disorder shows multi-faceted characteristics different from unipolar depression
- Quetiapine is an atypical antipsychotic licensed for treatment of bipolar depression
- The aim of this study is to investigate the pattern of neurophysiologic dysregulation in bipolar depression and its changes induced by quetiapine treatment
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bipolar depression | Experimental | Drug: Quetiapineunmedicated patients with bipolar depression receiving quetiapine treatment |
| Control | No intervention | –healthy controls matched for age, gender, and body mass index |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DSM-IV bipolar disorder I or II
- Depressive phase
- Drug-naive or drug-free
Key exclusion criteria (3 listed)
- Serious medical or neurological conditions
- DSM-IV substance-related disorders (within 12 months prior to participation)
- Mentally retarded
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 |
|---|---|---|
| QuetiapineAlso: Seroqueloral tablet/25-600mg per day/once a day/six weeks | Drug | bipolar depression |
Primary outcome
Heart Rate Variability
Time frame: Six weeks
heart rate variability parameters of time/frequency/complexity domains
4 secondary outcomes
Cardio-Respiratory Coupling
Time frame: Six weeks
Electroencephalographic Changes
Time frame: Six weeks
Severity of Mood Symptoms
Time frame: Six weeks
Severity of Extrapyramidal Symptom Scale
Time frame: Six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
- Background: PubMed 20083149Berger S, Boettger MK, Tancer M, Guinjoan SM, Yeragani VK, Bar KJ. Reduced cardio-respiratory coupling indicates suppression of vagal activity in healthy relatives of patients with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Mar 17;34(2):406-11. doi: 10.1016/j.pnpbp.2010.01.009. Epub 2010 Jan 18.
- Background: PubMed 20538342Bar KJ, Schuhmacher A, Hofels S, Schulz S, Voss A, Yeragani VK, Maier W, Zobel A. Reduced cardio-respiratory coupling after treatment with nortriptyline in contrast to S-citalopram. J Affect Disord. 2010 Dec;127(1-3):266-73. doi: 10.1016/j.jad.2010.05.010. Epub 2010 Jun 9.
- Background: PubMed 19427888Chang JS, Yoo CS, Yi SH, Hong KH, Oh HS, Hwang JY, Kim SG, Ahn YM, Kim YS. Differential pattern of heart rate variability in patients with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Aug 31;33(6):991-5. doi: 10.1016/j.pnpbp.2009.05.004. Epub 2009 May 7.
- Background: PubMed 20138254Kemp AH, Quintana DS, Gray MA, Felmingham KL, Brown K, Gatt JM. Impact of depression and antidepressant treatment on heart rate variability: a review and meta-analysis. Biol Psychiatry. 2010 Jun 1;67(11):1067-74. doi: 10.1016/j.biopsych.2009.12.012. Epub 2010 Feb 6.
- Background: PubMed 15219580Kemp AH, Gray MA, Silberstein RB, Armstrong SM, Nathan PJ. Augmentation of serotonin enhances pleasant and suppresses unpleasant cortical electrophysiological responses to visual emotional stimuli in humans. Neuroimage. 2004 Jul;22(3):1084-96. doi: 10.1016/j.neuroimage.2004.03.022.
- Click here for more information about recent updates on bipolar disorder researchLink provided by the sponsor.
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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.
Jae Seung Chang, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
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 Quetiapine in people with Bipolar Depression, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 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 21 Nov 2013. 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 South Korea. 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 Jae Seung Chang, M.D., Ph.D. (82-31-787-7437, cjs0107@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: Six 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 NCT01213121, which also lists 5 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 21 Nov 2013.