Network Analysis of Adult MDD and ADHD | NCT04504474

Studies
Network Analysis of Adult MDD and ADHD

NCT04504474

Sponsor

Health Sciences North Research Institute

Status

Unknown status

Last Update Posted

Aug 7, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

ADHD

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 21, 2018Actual

Primary Completion Date

Aug 8, 2021Estimated

Completion Date

Sep 8, 2021Estimated

First Submitted Date

Aug 5, 2020

First Submission Date that Met QC Criteria

Aug 5, 2020

First Posted Date

Aug 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2020

Last Update Posted Date

Aug 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is an investigation to determine co-morbid symptoms between adult major depressive disorder (MDD) and adult attention-deficit hyperactivity disorder (ADHD) using a novel statistical technique called network analysis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Co-morbidity	Characterize the ADHD/MDD symptom network in a psychiatric outpatient setting comprised of adults	September 8, 2021
Network reliability	Determine the stability and reliability of this network	September 8, 2021
Central symptoms	Determine the central symptoms that lead to co-activation of ADHD/MDD clusters	September 8, 2021

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

participants have a diagnosis of MDD or ADHD or both
participants are competent to consent to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

We will gather a recruitment of 500 male and female outpatients from the Psychiatric Outpatient Clinic at Kirkwood Site attached to Health Sciences North.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kuppuswami Shivakumar, M.D.	Contact	705-523-7100	8234	kshivakumar@hsnsudbury.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kirkwood Site - Health Sciences North	Recruiting	Greater Sudbury	Ontario	P3E 1X3	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

None of the IPD will be shared with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided