Bipolar DisorderNCT01583569
Complex Dynamic Systems in Mood Disorders
An observational study of Bipolar Disorder and Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Complex Dynamic Systems in Mood Disorders is an observational, exploratory study of the relationship between voice samples, heart rate, respiration, movement, galvanic skin conductance, and sleep architecture with mood states in patients with Major Depressive Disorder, Bipolar Disorder, and healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Major Depressive Disorder
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample will consist of subjects with Major Depressive Disorder(n=5), Bipolar Disorder (n=5), as well as healthy controls (n=5)
Who may be able to join
- Age > 18 and < 65.
- Meet DSM-IV criteria for MDD (n=5), BD (n=5), or healthy controls with no psychiatric diagnosis (n=5).
- Willing and able to wear a wearable device to measure sleep parameters
- Willing and able to provide voice samples.
- Subjects with MDD must not be taking psychiatric medications at the time of evaluation.Subjects with BD can be taking psychiatric medications, since it is not feasible for patients with BD to be completely free of mood stabilizing medications. These medications will be limited to lithium, second generation antipsychotics.
- Currently a patient or research participant at the DCRP or the BCRP or are healthy controls enrolled in evaluation studies.
Who cannot join
- Primary sleep disorder, including restless legs syndrome, difficulties in initiating and maintaining sleep.
- Movement disorders (e.g. Parkinson's, Huntington's, tardive dyskinesia, primary chorea).
- Active substance abuse or dependence in the past 3 months.
- Cardiovascular or pulmonary disease, including uncontrolled hypertension, arrhythmias, history of myocardial infarction, asthma, COPD, or pulmonary carcinoma.
- Cardiovascular or pulmonary medications (aspirin and statins are allowable).
- Anticonvulsants.
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- Sedative/hypnotics (e.g. benzodiazepines, eczopiclone).
- Smokers.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bipolar Clinic and Research Program at Massachusetts General Hospital
Boston, Massachusetts, 02144
About this study
Complex Dynamic Systems in Mood Disorders is an observational, exploratory study of the relationship between voice samples, heart rate, respiration, movement, galvanic skin conductance, and sleep architecture with mood states in patients with Major Depressive Disorder, Bipolar Disorder, and healthy controls. The overall hypothesis is that nonlinear dynamic analyses will be able to reveal hidden patterns of complexity in each domain of voice, heart rate variability, movement, arousal, and sleep stage data.
Read the detailed description
Aim 1: To assess multichannel physiologic measures associated with mood disorders.
Hypothesis: The overall hypothesis is that nonlinear dynamic analyses will be able to reveal hidden patterns of complexity in each domain of voice, heart rate variability (RR intervals), movement, arousal, and sleep stage data.
Aim 2: To assess differences in patterns and complexity of multiple physiological measures in patients with MDD compared to healthy controls.
Hypothesis: MDD will be associated with decreased measures of complexity and increased measures of approximate entropy compared to healthy controls.
Aim 3: To assess differences in patterns and complexity of multiple physiologic measures in patients with BD compared to healthy controls.
Hypothesis: BD will be associated with decreased measures of complexity and increased measures of approximate entropy compared to healthy controls.
Aim 4: To assess changes in patterns and complexity of multiple physiologic measures at baseline and after 2 weeks of treatment for patients with MDD and BD.
Hypothesis: Measures of complexity will increase and measures of approximate entropy will decrease in the first two weeks of treatment.
Aim 5: To assess the relationship between changes in patterns and complexity of multiple physiologic measures and changes in mood state.
Hypothesis: Measures of complexity will increase and measures of approximate entropy will decrease, especially for those who are much or very much improved
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Keywords
- Complex Dynamic Systems, Biomarkers, Mood Disorders
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Mood Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionDec 2014
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 Massachusetts General 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Andrew A. Nierenberg, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583569
- Sponsor's protocol ID
- 3273723
- Other IDs
- 1K18MH093939-01
- Status last verified
- Oct 2015
- First submitted
- 30 Mar 2012
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Dynamic Systems in Mood Disorders
- ClinicalTrials.gov ID
- NCT01583569
- Acronym / sponsor ID
- 3273723
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Keywords
- Complex Dynamic Systems, Biomarkers, Mood Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Apr 2012 (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.
Complex Dynamic Systems in Mood Disorders is an observational, exploratory study of the relationship between voice samples, heart rate, respiration, movement, galvanic skin conductance, and sleep architecture with mood states in patients with Major Depressive Disorder, Bipolar Disorder, and healthy controls. The overall hypothesis is that nonlinear dynamic analyses will be able to reveal hidden patterns of complexity in each domain of voice, heart rate variability, movement, arousal, and sleep stage data.
Detailed description
Aim 1: To assess multichannel physiologic measures associated with mood disorders.
Hypothesis: The overall hypothesis is that nonlinear dynamic analyses will be able to reveal hidden patterns of complexity in each domain of voice, heart rate variability (RR intervals), movement, arousal, and sleep stage data.
Aim 2: To assess differences in patterns and complexity of multiple physiological measures in patients with MDD compared to healthy controls.
Hypothesis: MDD will be associated with decreased measures of complexity and increased measures of approximate entropy compared to healthy controls.
Aim 3: To assess differences in patterns and complexity of multiple physiologic measures in patients with BD compared to healthy controls.
Hypothesis: BD will be associated with decreased measures of complexity and increased measures of approximate entropy compared to healthy controls.
Aim 4: To assess changes in patterns and complexity of multiple physiologic measures at baseline and after 2 weeks of treatment for patients with MDD and BD.
Hypothesis: Measures of complexity will increase and measures of approximate entropy will decrease in the first two weeks of treatment.
Aim 5: To assess the relationship between changes in patterns and complexity of multiple physiologic measures and changes in mood state.
Hypothesis: Measures of complexity will increase and measures of approximate entropy will decrease, especially for those who are much or very much improved
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample will consist of subjects with Major Depressive Disorder(n=5), Bipolar Disorder (n=5), as well as healthy controls (n=5)
Key inclusion criteria (6 listed)
- Age > 18 and < 65.
- Meet DSM-IV criteria for MDD (n=5), BD (n=5), or healthy controls with no psychiatric diagnosis (n=5).
- Willing and able to wear a wearable device to measure sleep parameters
- Willing and able to provide voice samples.
- Subjects with MDD must not be taking psychiatric medications at the time of evaluation.Subjects with BD can be taking psychiatric medications, since it is not feasible for patients with BD to be completely free of mood stabilizing medications. These medications will be limited to lithium, second generation antipsychotics.
Key exclusion criteria (9 listed)
- Primary sleep disorder, including restless legs syndrome, difficulties in initiating and maintaining sleep.
- Movement disorders (e.g. Parkinson's, Huntington's, tardive dyskinesia, primary chorea).
- Active substance abuse or dependence in the past 3 months.
- Cardiovascular or pulmonary disease, including uncontrolled hypertension, arrhythmias, history of myocardial infarction, asthma, COPD, or pulmonary carcinoma.
- Cardiovascular or pulmonary medications (aspirin and statins are allowable).
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
Not reported in the source record.
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 7 Oct 2015.
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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 Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 7 Oct 2015. 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 United States. 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.
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 7 Oct 2015.