Complex Dynamic Systems in Mood Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrew A. Nierenberg, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01583569
First received: March 30, 2012
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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.


Condition
Bipolar Disorder
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Complex Dynamic Systems in Mood Disorders

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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)

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583569

Contacts
Contact: Stephanie Salcedo, B.A. 617-724-9033 ssalcedo@partners.org

Locations
United States, Massachusetts
Bipolar Clinic and Research Program at Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02144
Contact: Stephanie Salcedo, B.A.    617-724-9033    ssalcedo@partners.org   
Principal Investigator: Andrew Nierenberg, MD         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Andrew A. Nierenberg, MD, Director of Research, Bipolar Clinic and Research Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01583569     History of Changes
Other Study ID Numbers: 3273723, 1K18MH093939-01
Study First Received: March 30, 2012
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Complex Dynamic Systems
Biomarkers
Mood Disorders

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 26, 2014