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Complex Dynamic Systems in Mood Disorders

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ClinicalTrials.gov Identifier: NCT01583569
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : October 7, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Andrew A. Nierenberg, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date March 30, 2012
First Posted Date April 24, 2012
Last Update Posted Date October 7, 2015
Study Start Date November 2011
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01583569 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Complex Dynamic Systems in Mood Disorders
Official Title Complex Dynamic Systems in Mood Disorders
Brief 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. 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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition
  • Bipolar Disorder
  • Major Depressive Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 5, 2015)
20
Original Estimated Enrollment
 (submitted: April 23, 2012)
30
Actual Study Completion Date December 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01583569
Other Study ID Numbers 3273723
1K18MH093939-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andrew A. Nierenberg, MD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators National Institute of Mental Health (NIMH)
Investigators Not Provided
PRS Account Massachusetts General Hospital
Verification Date October 2015