Bipolar DisorderNCT01455038
Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase
An observational study of Bipolar Disorder and Subsyndromal Depressive Phase, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purposes of this study were: (1) to compare heart rate variability between bipolar patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation between the severity of subsyndromal depressive symptoms and reduced heart rate variability. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Subsyndromal Depressive Phase, Heart Rate Variability
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Apr 2010
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Thirty three (10 males, 23 females) patients in clinically remitted state diagnosed with bipolar disorder based on DSM-IV criteria were enrolled at one outpatient psychiatric clinic and 59 healthy controls (23 males, 36 females) from health promotion center in a university-affiliated general hospital. We defined an individual patient as being in subsyndromal depressive phase when the patient had a Montgomery-Åsberg depression rating scale (MADRS) score of 10 or less and Clinical Global Impression severity (CGI-S) of 3 or less for last one month. Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.
Who may be able to join
- Bipolar group:
- DSM-IV bipolar disorder
- Montgomery-Åsberg depression rating scale (MADRS) score for last one month : ≤ 10
- Clinical Global Impression severity (CGI-S) for last one month : ≤ 3
- Healthy controls group: Subjects had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.
Who cannot join
- Psychiatric disorder except bipolar disorder
- Neurological symptoms or signs
- History of head trauma
- History of cardiovascular diseases
- Any medication except psychiatric medication.
Trial locations and contacts
1 site in 1 country.
About this study
The purposes of this study were: (1) to compare heart rate variability between bipolar patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation between the severity of subsyndromal depressive symptoms and reduced heart rate variability.
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist. | |
| Bipolar group | individual patient as being in subsyndromal depressive phase when the patient had a Montgomery-Åsberg depression rating scale score of 10 or less and Clinical Global Impression severity of 3 or less for last one month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (HRV)
Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (Number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50(NN50/total number of all NN).
Frequency domain - TP (The variance of NN intervals over the temporal segment), VLF(Power in very low frequency range; <0.04 Hz), LF(Power in low frequency range; 0.04~0.15 Hz), HF(Power in high frequency range; 0.15~0.4 Hz)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Health Technology R&D Project, Ministry of Health & Welfare
- Responsible party
- Principal investigator, Yeon-Ho Joo, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455038
- Sponsor's protocol ID
- A090116
- Status last verified
- Oct 2011
- First submitted
- 18 Oct 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase
- ClinicalTrials.gov ID
- NCT01455038
- Acronym / sponsor ID
- A090116
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korean Health Technology R&D Project, Ministry of Health & Welfare
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 19 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.
The purposes of this study were: (1) to compare heart rate variability between bipolar patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation between the severity of subsyndromal depressive symptoms and reduced heart rate variability.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist. |
| Bipolar group | – | –individual patient as being in subsyndromal depressive phase when the patient had a Montgomery-Åsberg depression rating scale score of 10 or less and Clinical Global Impression severity of 3 or less for last one month. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Thirty three (10 males, 23 females) patients in clinically remitted state diagnosed with bipolar disorder based on DSM-IV criteria were enrolled at one outpatient psychiatric clinic and 59 healthy controls (23 males, 36 females) from health promotion center in a university-affiliated general hospital. We defined an individual patient as being in subsyndromal depressive phase when the patient had a Montgomery-Åsberg depression rating scale (MADRS) score of 10 or less and Clinical Global Impression severity (CGI-S) of 3 or less for last one month. Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.
Key inclusion criteria (5 listed)
- Bipolar group:
- Healthy controls group: Subjects had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.
Key exclusion criteria (5 listed)
- Psychiatric disorder except bipolar disorder
- Neurological symptoms or signs
- History of head trauma
- History of cardiovascular diseases
- Any medication except psychiatric medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart rate variability (HRV)
Time frame: at baseline
Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (Number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50(NN50/total number of all NN). Frequency domain - TP (The variance of NN intervals over the temporal segment), VLF(Power in very low frequency range; <0.04 Hz), LF(Power in low frequency range; 0.04~0.15 Hz), HF(Power in high frequency range; 0.15~0.4 Hz)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Subsyndromal Depressive Phase, run by Asan Medical Center 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Oct 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (HRV) (time frame: at baseline). 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 19 Oct 2011.