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Far Infrared Radiation Treatment for Bipolar Condition

Primary Purpose

Bipolar Disorder

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Far infrared
Sponsored by
GAAD Medical Research Institute Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Affective Psychosis, Bipolar, Depression, Bipolar, Mania, Manic Disorder, Manic State, Manic-Depressive Psychosis, Psychoses, Manic-Depressive, Psychosis, Manic-Depressive

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Centre for Incurable Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

The primary end point is to determine the therapeutic effects of far infrared radiation on bipolar condition.

Secondary Outcome Measures

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.

Full Information

First Posted
December 12, 2007
Last Updated
August 14, 2009
Sponsor
GAAD Medical Research Institute Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00573196
Brief Title
Far Infrared Radiation Treatment for Bipolar Condition
Official Title
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Bipolar Condition
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
GAAD Medical Research Institute Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Affective Psychosis, Bipolar, Depression, Bipolar, Mania, Manic Disorder, Manic State, Manic-Depressive Psychosis, Psychoses, Manic-Depressive, Psychosis, Manic-Depressive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Far infrared
Intervention Description
Far infrared radiation (5μm to 15μm wavelength)
Primary Outcome Measure Information:
Title
The primary end point is to determine the therapeutic effects of far infrared radiation on bipolar condition.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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.
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwasi Donyina, Ph.D.
Organizational Affiliation
GAAD Medical Research Institute Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ken Nedd, M.D.
Organizational Affiliation
GAAD Medical Research Institute Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Centre for Incurable Diseases
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5R 3G9
Country
Canada

12. IPD Sharing Statement

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