Complex Dynamic Systems in Mood Disorders

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01583569
Study type	Observational
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	N/A
Start date	November 2011
Completion date	December 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.