Taurine in Adolescents With Bipolar Disorder

NCT00391001 | Terminated Phase 1

• 1 other identifier: CHA-IRB-0131/09/05
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Bipolar Disorder

Keywords

mania; bipolar disorder; taurine; adolescents

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale (YMRS; 11 item structured interview; Young et al 1978).

  weekly

Study Arms (2)

1

EXPERIMENTAL

Drug: Taurine

2

PLACEBO COMPARATOR

Drug: Taurine

Interventions

Taurine DRUG

double-blind, placebo-controlled, adjunctive medication

1; 2

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• Stanley Medical Research Institute: collaborator
• Mclean Hospital: collaborator

Study Sites (2)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Cambridge Health Alliance Child & Adolescent Neuropsychiatric Research Program

Medford, Massachusetts, 02155, United States

Location

Related Publications (4)

• 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.

  PMID: 9684263 BACKGROUND

• Stoll 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.

  PMID: 10232294 BACKGROUND

• Thornton 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.

  PMID: 1899989 BACKGROUND

• Van 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.

  PMID: 807299 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

Taurine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Jean Frazier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 23, 2006
• Study Start: February 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: February 3, 2010

Record last verified: 2008-06

Locations

US (2)