NCT00573196

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 17, 2009

Status Verified

August 1, 2009

Enrollment Period

1.4 years

First QC Date

December 12, 2007

Last Update Submit

August 14, 2009

Conditions

Bipolar Disorder

Keywords

Affective Psychosis, BipolarDepression, BipolarManiaManic DisorderManic StateManic-Depressive PsychosisPsychoses, Manic-DepressivePsychosis, Manic-Depressive

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL
Radiation: Far infrared

Interventions

Far infraredRADIATION

Far infrared radiation (5μm to 15μm wavelength)

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Centre for Incurable Diseases

Mississauga, Ontario, L5R 3G9, Canada

Location

MeSH Terms

Conditions

Bipolar DisorderMania

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kwasi Donyina, Ph.D.

    GAAD Medical Research Institute Inc.

    PRINCIPAL INVESTIGATOR

  • Ken Nedd, M.D.

    GAAD Medical Research Institute Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 14, 2007

Study Start

September 1, 2006

Primary Completion

February 1, 2008

Study Completion

June 1, 2008

Last Updated

August 17, 2009

Record last verified: 2009-08

Locations

CA(1)