- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01583569
Complex Dynamic Systems in Mood Disorders
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02144
- Bipolar Clinic and Research Program at Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Sedative/hypnotics (e.g. benzodiazepines, eczopiclone).
- Smokers.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3273723
- 1K18MH093939-01 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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