Far Infrared Radiation Treatment for Bipolar Condition | NCT00573196

Studies
Far Infrared Radiation Treatment for Bipolar Condition

NCT00573196

Sponsor

GAAD Medical Research Institute Inc.

Status

Unknown status

Last Update Posted

Aug 17, 2009Estimated

Enrollment

3Actual

Phase

Phase 1

Conditions

Bipolar Disorder

Interventions

Far infrared

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 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Feb 2008Actual

Completion Date

Jun 2008Estimated

First Submitted Date

Dec 12, 2007

First Submission Date that Met QC Criteria

Dec 12, 2007

First Posted Date

Dec 14, 2007Estimated

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 14, 2009

Last Update Posted Date

Aug 17, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A preliminary study to determine the possibility of using far infrared radiation for the treatment of the Bipolar Condition

Detailed Description

A 2000 study in the American Journal of Psychiatry reported that, "in those with bipolar, two major areas of the brain contain 30 percent more cells that send signals to other brain cells". This fact explains why famous people with the Bipolar condition like astronaut Buzz Aldrin, financier Robert Campeau, British Prime Minister Winston Churchill, composer Mozart, scientist Isaac Newton, physician Sigmund Freud and media giant & entrepreneur Ted Turner, excelled in life due to the additional brain power!

The excessive brain power, however, had to be controlled occasionally with mood stabilizers. Mood stabilizers include a number of anticonvulsants and Lithium. These medications, however, have adverse side effects on the kidneys. The proposed evaluation does not have any adverse health effects.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Radiation: Far infrared

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Far infrared	Radiation	Far infrared radiation (5μm to 15μm wavelength)	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary end point is to determine the therapeutic effects of far infrared radiation on bipolar condition.		2 years

Secondary Outcomes

Measure	Description	Time Frame
The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related mental illness including Depression, Anxiety, Stress and Insomnia.		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persons with Bipolar Condition, Depression, Anxiety, Stress and Insomnia

Exclusion Criteria:

Persons with severe mental illness that are confined to mental hospitals etc. as defined by the USA Diagnostic and Statistical Manual of Mental Disorders (DSM) are excluded from this clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kwasi Donyina, Ph.D.	GAAD Medical Research Institute Inc.	Principal Investigator
Ken Nedd, M.D.	GAAD Medical Research Institute Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Centre for Incurable Diseases		Mississauga	Ontario	L5R 3G9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder
D000087122	Mania

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D019954	Neurobehavioral Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided