Bipolar DisorderPhase 1NCT00391001
Taurine in Adolescents With Bipolar Disorder
A Phase 1 study testing Taurine in people with Bipolar Disorder, run by Cambridge Health Alliance at 2 sites in United States.
Trial summary
Recently, McLean hospital conducted a 4 month taurine study which showed a reduction in mania ratings. As a follow-up to the preliminary taurine study, and complementary to the currently ongoing double-blind, placebo-controlled trial for taurine in adults with bipolar disorder, this study will target adolescent… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Taurine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to Aug 2007
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects must meet DSM-IV-TR criteria for bipolar disorder (type I), and current hypomania, mania, or mixed mania.
- Subjects must be between the ages of 13 through 18 years.
- Medications ("treatment-as-usual") stable x2 weeks
- Subjects must be able to assent to their participation in the study.
- Subjects must agree to avoid taking supplemental taurine (e.g. from over-the-counter preparations, energy drinks, etc).
Who cannot join
- Co-morbid serious mental illness.
- Significant medical or neurological illness, including: seizure disorders, severe respiratory illness or cardiac conditions, known cerebrovascular disease, hypo- or hypertension, diabetes mellitus, and immune, endocrine, renal or hepatic dysfunction (the study team does not wish to enroll any subjects at increased risk for complications or who require additional clinical monitoring due to their medical illness).
- Pregnant subjects. It is not known what effects taurine supplementation would have on a fetus. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded.
- Patients who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or patients who will not likely be able to comply with the study protocol.
- Patients who meet DSM-IV-TR criteria for current substance abuse or substance dependence.
- Patients who are regularly taking supplemental taurine at the time of screening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McLean Hospital
Belmont, Massachusetts, 02478
Cambridge Health Alliance Child & Adolescent Neuropsychiatric Research Program
Medford, Massachusetts, 02155
About this study
Official title: Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study in Adolescents With Bipolar Disorder
Recently, McLean hospital conducted a 4 month taurine study which showed a reduction in mania ratings. As a follow-up to the preliminary taurine study, and complementary to the currently ongoing double-blind, placebo-controlled trial for taurine in adults with bipolar disorder, this study will target adolescent bipolar subjects (type I) with symptoms of mania or mixed mania. To our knowledge, this would be the first study to evaluate the effects of the novel compound taurine in adolescent subjects with bipolar disorder.
We hypothesize there will be a positive response in some adolescents from taurine treatment, and this positive response will be greater than that expected by chance. This study may demonstrate that taurine is a well-tolerated and effective adjunct treatment for mania in bipolar disorder.
Read the detailed description
A cohort of adolescent (ages 13-18) patients with bipolar disorder and current manic symptoms will be approached for participation in this 3-month outpatient study. Taurine or matching placebo will be administered orally, in capsules, and added to whatever medication(s) the patients are receiving from their clinicians. The specific medications and dosages will be determined solely by the subjects' non-study clinicians ("treatment-as-usual"). During the 3 months of the study, subjects will be required to keep their medications nearly constant (minor dosage adjustments for side-effects or to maintain therapeutic levels will be permitted) for the duration of the trial. Since taurine will be an adjunctive therapy, patients currently taking mood stabilizers can continue to do so. The research team will work closely with the subject and their outpatient clinician(s) to coordinate the medication issues. The results from standard rating scales for bipolar disorder research will be compared between the group receiving the taurine and the group receiving placebo.
The sample will include thirty adolescent (ages 13-18) outpatients with bipolar disorder, type I. The study will be 3 months long.
Study Drugs: The cohort will be randomized to receive either taurine or matching placebo (microcellulose). Taurine and placebo will be provided in 500 mg vegetable capsules.
Follow-up visits and clinical ratings:
During the baseline visit, a detailed psychiatric and medical history will be obtained. The adolescent will start study medicine at that time. The following standard rating scales will be performed:
- Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Episode (K-SADS-PL) with additional mood onset and offset items derived from the WASH-U K-SADS (K-SADS-PL-W) (Kaufman 1997).
- Young Mania Rating Scale (YMRS; 11 item structured interview; Young et al 1978).
- Children's Depression Rating Scale - Revised (CDRS-R; Overholser 1995).
- The ADHD Rating Scale (ARS-IV; DuPaul 1998).
- Clinical Global Impression scale - Bipolar version (CGI-BP; Guy 1976).
- Children's Global Assessment Scale (CGAS; Shaffer 1995).
- Montgomery-Asberg Depression rating Scale (MADRS; Montgomery \& Asberg 1979).
- Brief Adverse Effect Rating Scale.
- Brief Psychiatric Rating Scale for Children (BPRS-C; Overall \& Pfefferbaum 1982).
- Safety Assessment (derived from our group's ongoing treatment studies).
After the baseline evaluation, subjects will be evaluated every week for 1 month, and then every 2 weeks for the remainder of the 3 months. The same rating scales will be performed at each follow-up visit, except for the KSADS-PL-W and the ARS-IV. Instead of the full KSADS-PL-W at the follow-up visits, only the screening questions for mania and depression will be performed in order to aid in the determination of syndromic recovery or recurrence. In addition, patients will maintain a daily Mood Diary, which will be reviewed at each study visit to elicit symptom recall.
All ratings will be performed by blind study personnel, who will not know whether the patient is receiving taurine or placebo.
- Conditions
- Bipolar Disorder
- Being tested
- Taurine
- Keywords
- mania, bipolar disorder, taurine, adolescents
- 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.
TaurineDrug
double-blind, placebo-controlled, adjunctive medication
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Taurine |
| 2 | Placebo comparator | Not described Receives: Drug: Taurine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Young Mania Rating Scale (YMRS; 11 item structured interview; Young et al 1978).
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startFeb 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute, Mclean Hospital
- Investigators
- Jean Frazier, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391001
- Sponsor's protocol ID
- CHA-IRB-0131/09/05
- Status last verified
- Jun 2008
- First submitted
- 19 Oct 2006
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Redmond HP, Stapleton PP, Neary P, Bouchier-Hayes D. Immunonutrition: the role of taurine. Nutrition. 1998 Jul-Aug;14(7-8):599-604. doi: 10.1016/s0899-9007(98)00097-5.
PubMed 9684263Stoll AL, Severus WE, Freeman MP, Rueter S, Zboyan HA, Diamond E, Cress KK, Marangell LB. Omega 3 fatty acids in bipolar disorder: a preliminary double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1999 May;56(5):407-12. doi: 10.1001/archpsyc.56.5.407.
PubMed 10232294Thornton L, Griffin E. Evaluation of a taurine containing amino acid solution in parenteral nutrition. Arch Dis Child. 1991 Jan;66(1 Spec No):21-5. doi: 10.1136/adc.66.1_spec_no.21.
PubMed 1899989Van Gelder NM, Sherwin AL, Sacks C, Anderman F. Biochemical observations following administration of taurine to patients with epilepsy. Brain Res. 1975 Aug 29;94(2):297-306. doi: 10.1016/0006-8993(75)90063-3.
PubMed 807299
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. 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 in Adolescents With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00391001
- Acronym / sponsor ID
- CHA-IRB-0131/09/05
- Conditions
- Bipolar Disorder
- Keywords
- mania, bipolar disorder, taurine, adolescents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute, Mclean Hospital
- Study start
- Feb 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 23 Oct 2006 (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.
Recently, McLean hospital conducted a 4 month taurine study which showed a reduction in mania ratings. As a follow-up to the preliminary taurine study, and complementary to the currently ongoing double-blind, placebo-controlled trial for taurine in adults with bipolar disorder, this study will target adolescent bipolar subjects (type I) with symptoms of mania or mixed mania. To our knowledge, this would be the first study to evaluate the effects of the novel compound taurine in adolescent subjects with bipolar disorder.
We hypothesize there will be a positive response in some adolescents from taurine treatment, and this positive response will be greater than that expected by chance. This study may demonstrate that taurine is a well-tolerated and effective adjunct treatment for mania in bipolar disorder.
Detailed description
A cohort of adolescent (ages 13-18) patients with bipolar disorder and current manic symptoms will be approached for participation in this 3-month outpatient study. Taurine or matching placebo will be administered orally, in capsules, and added to whatever medication(s) the patients are receiving from their clinicians. The specific medications and dosages will be determined solely by the subjects' non-study clinicians ("treatment-as-usual"). During the 3 months of the study, subjects will be required to keep their medications nearly constant (minor dosage adjustments for side-effects or to maintain therapeutic levels will be permitted) for the duration of the trial. Since taurine will be an adjunctive therapy, patients currently taking mood stabilizers can continue to do so. The research team will work closely with the subject and their outpatient clinician(s) to coordinate the medication issues. The results from standard rating scales for bipolar disorder research will be compared between the group receiving the taurine and the group receiving placebo.
The sample will include thirty adolescent (ages 13-18) outpatients with bipolar disorder, type I. The study will be 3 months long.
Study Drugs: The cohort will be randomized to receive either taurine or matching placebo (microcellulose). Taurine and placebo will be provided in 500 mg vegetable capsules.
Follow-up visits and clinical ratings:
During the baseline visit, a detailed psychiatric and medical history will be obtained. The adolescent will start study medicine at that time. The following standard rating scales will be performed:
- Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Episode (K-SADS-PL) with additional mood onset and offset items derived from the WASH-U K-SADS (K-SADS-PL-W) (Kaufman 1997).
- Young Mania Rating Scale (YMRS; 11 item structured interview; Young et al 1978).
- Children's Depression Rating Scale - Revised (CDRS-R; Overholser 1995).
- The ADHD Rating Scale (ARS-IV; DuPaul 1998).
- Clinical Global Impression scale - Bipolar version (CGI-BP; Guy 1976).
- Children's Global Assessment Scale (CGAS; Shaffer 1995).
- Montgomery-Asberg Depression rating Scale (MADRS; Montgomery \& Asberg 1979).
- Brief Adverse Effect Rating Scale.
- Brief Psychiatric Rating Scale for Children (BPRS-C; Overall \& Pfefferbaum 1982).
- Safety Assessment (derived from our group's ongoing treatment studies).
After the baseline evaluation, subjects will be evaluated every week for 1 month, and then every 2 weeks for the remainder of the 3 months. The same rating scales will be performed at each follow-up visit, except for the KSADS-PL-W and the ARS-IV. Instead of the full KSADS-PL-W at the follow-up visits, only the screening questions for mania and depression will be performed in order to aid in the determination of syndromic recovery or recurrence. In addition, patients will maintain a daily Mood Diary, which will be reviewed at each study visit to elicit symptom recall.
All ratings will be performed by blind study personnel, who will not know whether the patient is receiving taurine or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Taurine |
| 2 | Placebo comparator | Drug: Taurine |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subjects must meet DSM-IV-TR criteria for bipolar disorder (type I), and current hypomania, mania, or mixed mania.
- Subjects must be between the ages of 13 through 18 years.
- Medications ("treatment-as-usual") stable x2 weeks
- Subjects must be able to assent to their participation in the study.
- Subjects must agree to avoid taking supplemental taurine (e.g. from over-the-counter preparations, energy drinks, etc).
Key exclusion criteria (6 listed)
- Co-morbid serious mental illness.
- Significant medical or neurological illness, including: seizure disorders, severe respiratory illness or cardiac conditions, known cerebrovascular disease, hypo- or hypertension, diabetes mellitus, and immune, endocrine, renal or hepatic dysfunction (the study team does not wish to enroll any subjects at increased risk for complications or who require additional clinical monitoring due to their medical illness).
- Pregnant subjects. It is not known what effects taurine supplementation would have on a fetus. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded.
- Patients who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or patients who will not likely be able to comply with the study protocol.
- Patients who meet DSM-IV-TR criteria for current substance abuse or substance 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 |
|---|---|---|
| Taurinedouble-blind, placebo-controlled, adjunctive medication | Drug | 1, 2 |
Primary outcome
Young Mania Rating Scale (YMRS; 11 item structured interview; Young et al 1978).
Time frame: weekly
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
- Background: PubMed 9684263Redmond HP, Stapleton PP, Neary P, Bouchier-Hayes D. Immunonutrition: the role of taurine. Nutrition. 1998 Jul-Aug;14(7-8):599-604. doi: 10.1016/s0899-9007(98)00097-5.
- Background: PubMed 10232294Stoll AL, Severus WE, Freeman MP, Rueter S, Zboyan HA, Diamond E, Cress KK, Marangell LB. Omega 3 fatty acids in bipolar disorder: a preliminary double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1999 May;56(5):407-12. doi: 10.1001/archpsyc.56.5.407.
- Background: PubMed 1899989Thornton L, Griffin E. Evaluation of a taurine containing amino acid solution in parenteral nutrition. Arch Dis Child. 1991 Jan;66(1 Spec No):21-5. doi: 10.1136/adc.66.1_spec_no.21.
- Background: PubMed 807299Van Gelder NM, Sherwin AL, Sacks C, Anderman F. Biochemical observations following administration of taurine to patients with epilepsy. Brain Res. 1975 Aug 29;94(2):297-306. doi: 10.1016/0006-8993(75)90063-3.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
Jean Frazier, MD principal investigator
Cambridge Health Alliance
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Taurine in people with Bipolar Disorder, run by Cambridge Health Alliance at 2 sites 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
The study was stopped early. 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?
Young Mania Rating Scale (YMRS; 11 item structured interview; Young et al 1978). (time frame: weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391001, which also lists 4 linked publications.
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 3 Feb 2010.