Bipolar DisorderPhase 2NCT00217165
Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study
A Phase 2 study testing taurine in people with Bipolar Disorder and Mania, run by Mclean Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the amino acid taurine has effects on mood stability in bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Bipolar Disorder, Mania, Bipolar Depression
- What is being tested?
- taurine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Dec 2011
- Phase
- Phase 2
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bipolar disorder, type I bipolar disorder, type II mania hypomania mixed manic symptoms
Who cannot join
- significant medical or psychiatric co-morbidity pregnancy or planning pregnancy current substance abuse or dependence
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Taurine as an Anti-manic Agent: a Double-blind Placebo-controlled Study.
The purpose of this study is to determine whether the amino acid taurine has effects on mood stability in bipolar disorder.
Read the detailed description
Taurine is an amino acid that has some actions similar to mood stabilizers. Taurine is widely sold as a component of over-the-counter mood enhancing agents. However, controlled studies examining the mood effects of taurine are limited. An initial study in this laboratory looked at taurine's mood effects in individuals with bipolar disorder. This follow-up study is designed to further examine taurine's effects on manic symptoms. Subjects in the current follow-up study will add taurine or placebo to their current treatment regimen. Both depressive and manic symptoms will be tracked for three months to determine whether the addition of taurine affects mood symptoms.
- Conditions
- Bipolar Disorder, Mania, Bipolar Depression
- Being tested
- taurine
- Keywords
- bipolar, mania, depression, taurine, alternative
- Medical subject headings
- Bipolar Disorder, Mania, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taurineDrug
taurine 2mg BID po
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | cellulose Receives: Drug: taurine |
| active drug | Active comparator | taurine Receives: Drug: taurine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)
MADRS and YMRS
Measured: 12 weeks
Secondary outcomes (2)
Side-effect ratings, general health ratings
SF36
Measured: 12 weeks
Drop-outs due to medication changes
subjects leaving study before completion
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2010
- Study completionDec 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth L. Murphy MD, PhD, Mclean Hospital
- Investigators
- Beth L Murphy, MD, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217165
- Sponsor's protocol ID
- 2004P-002669
- Status last verified
- Feb 2019
- First submitted
- 22 Aug 2005
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taurine as an Anti-manic Agent: a Double-blind Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT00217165
- Acronym / sponsor ID
- 2004P-002669
- Conditions
- Bipolar Disorder, Mania, Bipolar Depression
- Keywords
- bipolar, mania, depression, taurine, alternative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Sep 2005 (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.
The purpose of this study is to determine whether the amino acid taurine has effects on mood stability in bipolar disorder.
Detailed description
Taurine is an amino acid that has some actions similar to mood stabilizers. Taurine is widely sold as a component of over-the-counter mood enhancing agents. However, controlled studies examining the mood effects of taurine are limited. An initial study in this laboratory looked at taurine's mood effects in individuals with bipolar disorder. This follow-up study is designed to further examine taurine's effects on manic symptoms. Subjects in the current follow-up study will add taurine or placebo to their current treatment regimen. Both depressive and manic symptoms will be tracked for three months to determine whether the addition of taurine affects mood symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: taurinecellulose |
| active drug | Active comparator | Drug: taurinetaurine |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bipolar disorder, type I bipolar disorder, type II mania hypomania mixed manic symptoms
Key exclusion criteria (2 listed)
- significant medical or psychiatric co-morbidity pregnancy or planning pregnancy current substance abuse or dependence
- -
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 |
|---|---|---|
| taurinetaurine 2mg BID po | Drug | active drug, placebo |
Primary outcome
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)
Time frame: 12 weeks
MADRS and YMRS
2 secondary outcomes
Side-effect ratings, general health ratings
Time frame: 12 weeks
Drop-outs due to medication changes
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- McLean Hospital website with links to research at the hospital.Link provided by the sponsor.
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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.
Beth L Murphy, MD, PhD 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 Phase 2 study testing taurine in people with Bipolar Disorder and Mania, 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 1 Mar 2019. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS) (time frame: 12 weeks). 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 1 Mar 2019.