Bipolar DisorderNCT00801567
Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation
A study testing Magnetic resonance spectroscopy (MRS) in people with Bipolar Disorder and Schizophrenia, run by Mclean Hospital at 1 site in United States.
Trial summary
This study aims to gather additional information to support the theory that bipolar disorder is due to cellular (mitochondrial) dysfunction. To test this theory adults with bipolar disorder who are not currently symptomatic will receive a one-time brain scan (magnetic resonance spectroscopy [MRS] scan) with light… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Schizophrenia, Healthy Controls
- What is being tested?
- Magnetic resonance spectroscopy (MRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2010
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male of female
- 18-55 years
- Bipolar, currently euthymic OR schizophrenia, stable, OR healthy control with no history of psychiatric illness
- On stable medication with no changes in the two weeks prior to enrollment
Who cannot join
- History of substance abuse or dependence within 3 months of enrollment
- Positive urine drug screen
- Significant medical or neurological illness
- Pregnancy
- Any contraindication to magnetic resonance scanning, including claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Magnetic Resonance Spectroscopy Study of Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation
This study aims to gather additional information to support the theory that bipolar disorder is due to cellular (mitochondrial) dysfunction. To test this theory adults with bipolar disorder who are not currently symptomatic will receive a one-time brain scan (magnetic resonance spectroscopy [MRS] scan) with light stimulation. To test whether any MRS findings are specific to bipolar disorder, healthy controls and adults with schizophrenia will also be included in this study.
Read the detailed description
This study will include males and females between the ages of 18 and 55 years. Participants will include adults with stable bipolar disorder or schizophrenia as well as healthy controls. The study involves a one-time visit that includes a clinical evaluation, laboratory tests, and a magnetic resonance scan that will last approximately 90 minutes. The procedures can also be separated into two study visits, if necessary.
- Conditions
- Bipolar Disorder, Schizophrenia, Healthy Controls
- Being tested
- Magnetic resonance spectroscopy (MRS)
- Keywords
- Bipolar disorder, Schizophrenia, Healthy volunteer, Brain imaging, Photic stimulation
- Medical subject headings
- Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance spectroscopy (MRS)Device
90-minute magnetic resonance scan.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All subjects will receive the intervention (MRS scan). Receives: Device: Magnetic resonance spectroscopy (MRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain levels of phosphocreatine (PCr), beta-nucleoside triphosphate (B-NTP), and intracellular pH (pHi).
Measured: 42 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startJun 2010
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Departure of essential Co-Investigator from McLean Hospital
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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian P. Brennan, MD, Mclean Hospital
- Investigators
- Brian P Brennan, MD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801567
- Sponsor's protocol ID
- 2008-P-001958
- Status last verified
- Mar 2012
- First submitted
- 2 Dec 2008
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Magnetic Resonance Spectroscopy Study of Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation
- ClinicalTrials.gov ID
- NCT00801567
- Acronym / sponsor ID
- 2008-P-001958
- Conditions
- Bipolar Disorder, Schizophrenia, Healthy Controls
- Keywords
- Bipolar disorder, Schizophrenia, Healthy volunteer, Brain imaging, Photic stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Departure of essential Co-Investigator from McLean Hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Dec 2008 (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.
This study aims to gather additional information to support the theory that bipolar disorder is due to cellular (mitochondrial) dysfunction. To test this theory adults with bipolar disorder who are not currently symptomatic will receive a one-time brain scan (magnetic resonance spectroscopy [MRS] scan) with light stimulation. To test whether any MRS findings are specific to bipolar disorder, healthy controls and adults with schizophrenia will also be included in this study.
Detailed description
This study will include males and females between the ages of 18 and 55 years. Participants will include adults with stable bipolar disorder or schizophrenia as well as healthy controls. The study involves a one-time visit that includes a clinical evaluation, laboratory tests, and a magnetic resonance scan that will last approximately 90 minutes. The procedures can also be separated into two study visits, if necessary.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Magnetic resonance spectroscopy (MRS)All subjects will receive the intervention (MRS scan). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male of female
- 18-55 years
- Bipolar, currently euthymic OR schizophrenia, stable, OR healthy control with no history of psychiatric illness
- On stable medication with no changes in the two weeks prior to enrollment
Key exclusion criteria (5 listed)
- History of substance abuse or dependence within 3 months of enrollment
- Positive urine drug screen
- Significant medical or neurological illness
- Pregnancy
- Any contraindication to magnetic resonance scanning, including claustrophobia
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 |
|---|---|---|
| Magnetic resonance spectroscopy (MRS)90-minute magnetic resonance scan. | Device | 1 |
Primary outcome
Change in brain levels of phosphocreatine (PCr), beta-nucleoside triphosphate (B-NTP), and intracellular pH (pHi).
Time frame: 42 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
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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.
Brian P Brennan, MD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance spectroscopy (MRS) in people with Bipolar Disorder and Schizophrenia, run by Mclean Hospital at 1 site in United States.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 12 Mar 2012. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in brain levels of phosphocreatine (PCr), beta-nucleoside triphosphate (B-NTP), and intracellular pH (pHi). (time frame: 42 minutes). 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 12 Mar 2012.