Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-28 @ 2:51 PM
Study NCT ID:
NCT01583569
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2012-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complex Dynamic Systems in Mood Disorders
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Complex Dynamic Systems in Mood Disorders
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K18MH093939-01 | NIH | None | https://reporter.nih.gov/quic… | View |