Complex Dynamic Systems in Mood Disorders

NCT01583569 | Completed

• 2 other identifiers: 32737231K18MH093939-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Major Depressive Disorder

Keywords

Complex Dynamic Systems; Biomarkers; Mood Disorders

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Bipolar Clinic and Research Program at Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major; Mood Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Depressive Disorder

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Bipolar Clinic and Research Program

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 24, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

US (1)