Bipolar DisorderPhase 1NCT00573196
Far Infrared Radiation Treatment for Bipolar Condition
A Phase 1 study testing Far infrared in people with Bipolar Disorder, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
Trial summary
A preliminary study to determine the possibility of using far infrared radiation for the treatment of the Bipolar Condition Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Far infrared
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persons with Bipolar Condition, Depression, Anxiety, Stress and Insomnia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Bipolar Condition
A preliminary study to determine the possibility of using far infrared radiation for the treatment of the Bipolar Condition
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Far infrared
- Keywords
- Affective Psychosis, Bipolar, Depression, Bipolar, Mania, Manic Disorder, Manic State, Manic-Depressive Psychosis, Psychoses, Manic-Depressive, Psychosis, Manic-Depressive
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far infraredRadiation
Far infrared radiation (5μm to 15μm wavelength)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Radiation: Far infrared |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is to determine the therapeutic effects of far infrared radiation on bipolar condition.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionFeb 2008
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- GAAD Medical Research Institute Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Kwasi Donyina, Ph.D., Principal investigator, GAAD Medical Research Institute Inc.Ken Nedd, M.D., Study director, GAAD Medical Research Institute Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573196
- Sponsor's protocol ID
- GAAD-BPC-CTP1
- Status last verified
- Aug 2009
- First submitted
- 12 Dec 2007
- Last updated
- 17 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Bipolar Condition
- ClinicalTrials.gov ID
- NCT00573196
- Acronym / sponsor ID
- GAAD-BPC-CTP1
- Conditions
- Bipolar Disorder
- Keywords
- Affective Psychosis, Bipolar, Depression, Bipolar, Mania, Manic Disorder, Manic State, Manic-Depressive Psychosis, Psychoses, Manic-Depressive, Psychosis, Manic-Depressive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GAAD Medical Research Institute Inc.University, hospital or other
- Study start
- Sep 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2008 (estimated)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: Far infrared |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Persons with Bipolar Condition, Depression, Anxiety, Stress and Insomnia
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Far infraredFar infrared radiation (5μm to 15μm wavelength) | Radiation | 1 |
Primary outcome
The primary end point is to determine the therapeutic effects of far infrared radiation on bipolar condition.
Time frame: 2 years
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2009.
Related trials for Bipolar Disorder
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 2
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Bipolar Disorder
RecruitingObservational study
Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
Esophageal Neoplasm, Esophageal Polyp
Recruiting
Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain
Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwasi Donyina, Ph.D. principal investigator
GAAD Medical Research Institute Inc.
Ken Nedd, M.D. study director
GAAD Medical Research Institute Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Far infrared in people with Bipolar Disorder, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point is to determine the therapeutic effects of far infrared radiation on bipolar condition. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2009.