Complex Dynamic Systems in Mood Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01583569|
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : October 7, 2015
|Condition or disease|
|Bipolar Disorder Major Depressive Disorder|
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|
|Actual Enrollment :||20 participants|
|Observational Model:||Case Control|
|Official Title:||Complex Dynamic Systems in Mood Disorders|
|Study Start Date :||November 2011|
|Primary Completion Date :||June 2014|
|Study Completion Date :||December 2014|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583569
|United States, Massachusetts|
|Bipolar Clinic and Research Program at Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02144|