Tourette SyndromeNCT00004325
Study of the Neurobiology of Tourette Syndrome and Related Disorders
An observational study of Tourette Syndrome and Obsessive Compulsive Disorder, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
OBJECTIVES: I. Investigate the pathobiology of Tourette syndrome and related disorders by measuring various compounds of interest in cerebrospinal fluid, plasma, and urine of patients with Tourette syndrome, obsessive compulsive disorder, and/or chronic tics. II. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Tourette Syndrome, Obsessive Compulsive Disorder
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1988to not given
- Phase
- Observational
- 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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnostic and Statistical Manual of Mental Disorders IV lifetime diagnosis of 1 or more of the following:
- Tourette syndrome (TS)
- Obsessive compulsive disorder
- Chronic tics
Severely affected adolescents with a score of 3 or greater on the TS-Clinical Global Impression Scale eligible
--Prior/Concurrent Therapy--
At least 1 month since any medication
--Patient Characteristics--
Other:
- In good physical health
- No alcohol or substance abuse
- No Intelligence Quotient below 80
- Negative pregnancy test required of fertile women
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520-8035
About this study
OBJECTIVES: I. Investigate the pathobiology of Tourette syndrome and related disorders by measuring various compounds of interest in cerebrospinal fluid, plasma, and urine of patients with Tourette syndrome, obsessive compulsive disorder, and/or chronic tics.
II. Determine the pattern of familial aggregation of Tourette syndrome and obsessive compulsive disorder by systematic assessment of all first-degree family members of patients selected for cerebrospinal fluid studies.
III. Establish the neurochemical and neuropeptide profile associated with the range of expression of the putative Tourette gene expression in adult and adolescent patients.
Read the detailed description
PROTOCOL OUTLINE: All patients are screened with a complete physical and neurologic exam, and a semi-structured interview. Patients then receive a comprehensive assessment of systemic disease. Patients and first-degree family members also participate in a genetic study.
Any patient who experiences an unusual exacerbation of symptoms or significant side effects is removed from the study.
- Conditions
- Tourette Syndrome, Obsessive Compulsive Disorder
- Keywords
- Tourette syndrome, anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, obsessive compulsive disorder, oncologic disorders, rare disease
- Medical subject headings
- Tourette Syndrome, Obsessive-Compulsive Disorder, Anxiety Disorders, Neurologic Manifestations, Mental Disorders, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startDec 1988
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies 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
- Observational
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Yale University
- Investigators
- James F. Leckman, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004325
- Sponsor's protocol ID
- 199/11866
- Other IDs
- YALESM-4601
- Status last verified
- Jan 2004
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
van Wattum PJ, Anderson GM, Chappell PB, Goodman WK, Riddle MA, Leckman JF. Cerebrospinal fluid dynorphin A[1-8] and beta-endorphin levels in Tourette's syndrome are unaltered. Biol Psychiatry. 1999 Jun 1;45(11):1527-8. doi: 10.1016/s0006-3223(98)00313-8. No abstract available.
PubMed 10356639Peterson BS, Leckman JF. The temporal dynamics of tics in Gilles de la Tourette syndrome. Biol Psychiatry. 1998 Dec 15;44(12):1337-48. doi: 10.1016/s0006-3223(98)00176-0.
PubMed 9861477Cohen DJ, Leckman JF, Pauls D. Neuropsychiatric disorders of childhood: Tourette's syndrome as a model. Acta Paediatr Suppl. 1997 Jul;422:106-11. doi: 10.1111/j.1651-2227.1997.tb18357.x.
PubMed 9298805Rasmusson AM, Anderson GM, Lynch KA, McSwiggan-Hardin M, Scahill LD, Mazure CM, Goodman WK, Price LH, Cohen DJ, Leckman JF. A preliminary study of tryptophan depletion on tics, obsessive-compulsive symptoms, and mood in Tourette's syndrome. Biol Psychiatry. 1997 Jan 1;41(1):117-21. doi: 10.1016/s0006-3223(96)00380-0. No abstract available.
PubMed 8988803Peterson BS, Leckman JF, Scahill L, Naftolin F, Keefe D, Charest NJ, King RA, Hardin MT, Cohen DJ. Steroid hormones and Tourette's syndrome: early experience with antiandrogen therapy. J Clin Psychopharmacol. 1994 Apr;14(2):131-5.
PubMed 8195454Chappell P, Leckman J, Goodman W, Bissette G, Pauls D, Anderson G, Riddle M, Scahill L, McDougle C, Cohen D. Elevated cerebrospinal fluid corticotropin-releasing factor in Tourette's syndrome: comparison to obsessive compulsive disorder and normal controls. Biol Psychiatry. 1996 May 1;39(9):776-83. doi: 10.1016/0006-3223(95)00221-9.
PubMed 8731518Chappell P, Riddle M, Anderson G, Scahill L, Hardin M, Walker D, Cohen D, Leckman J. Enhanced stress responsivity of Tourette syndrome patients undergoing lumbar puncture. Biol Psychiatry. 1994 Jul 1;36(1):35-43. doi: 10.1016/0006-3223(94)90060-4.
PubMed 8080901Martin A, State M, Anderson GM, Kaye WM, Hanchett JM, McConaha CW, North WG, Leckman JF. Cerebrospinal fluid levels of oxytocin in Prader-Willi syndrome: a preliminary report. Biol Psychiatry. 1998 Dec 15;44(12):1349-52. doi: 10.1016/s0006-3223(98)00190-5.
PubMed 9861478Leckman JF, Goodman WK, Anderson GM, Riddle MA, Chappell PB, McSwiggan-Hardin MT, McDougle CJ, Scahill LD, Ort SI, Pauls DL, et al. Cerebrospinal fluid biogenic amines in obsessive compulsive disorder, Tourette's syndrome, and healthy controls. Neuropsychopharmacology. 1995 Feb;12(1):73-86. doi: 10.1038/sj.npp.1380241.
PubMed 7766289Riddle MA, Jatlow PI, Anderson GM, Cho SC, Hardin MT, Cohen DJ, Leckman JF. Plasma debrisoquin levels in the assessment of reduction of plasma homovanillic acid. The debrisoquin method. Neuropsychopharmacology. 1989 Jun;2(2):123-9. doi: 10.1016/0893-133x(89)90015-8.
PubMed 2742727Anderson GM, Mefford IN, Tolliver TJ, Riddle MA, Ocame DM, Leckman JF, Cohen DJ. Serotonin in human lumbar cerebrospinal fluid: a reassessment. Life Sci. 1990;46(4):247-55. doi: 10.1016/0024-3205(90)90030-u.
PubMed 2304369Leckman JF, Goodman WK, Riddle MA, Hardin MT, Anderson GM. Low CSF 5HIAA and obsessions of violence: report of two cases. Psychiatry Res. 1990 Jul;33(1):95-9. doi: 10.1016/0165-1781(90)90152-u. No abstract available.
PubMed 1699245Leckman JF, Chittenden EH. Gilles de La Tourette's syndrome and some forms of obsessive-compulsive disorder may share a common genetic diathesis. Encephale. 1990 Jul-Aug;16 Spec No:321-3.
PubMed 2209489Leckman JF, Cohen DJ, Shaywitz BA, Caparulo BK, Heninger GR, Bowers MB Jr. CSF monoamine metabolites in child and adult psychiatric patients. A developmental perspective. Arch Gen Psychiatry. 1980 Jun;37(6):677-81. doi: 10.1001/archpsyc.1980.01780190075009.
PubMed 6155891Shaywitz BA, Cohen DJ, Leckman JF, Young JG, Bowers MB Jr. Ontogeny of dopamine and serotonin metabolites in the cerebrospinal fluid of children with neurological disorders. Dev Med Child Neurol. 1980 Dec;22(6):748-54. doi: 10.1111/j.1469-8749.1980.tb03741.x.
PubMed 6161049
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Neurobiology of Tourette Syndrome and Related Disorders
- ClinicalTrials.gov ID
- NCT00004325
- Acronym / sponsor ID
- 199/11866
- Conditions
- Tourette Syndrome, Obsessive Compulsive Disorder
- Keywords
- Tourette syndrome, anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, obsessive compulsive disorder, oncologic disorders, rare disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Yale University
- Study start
- Dec 1988
- First posted
- 19 Oct 1999 (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.
OBJECTIVES: I. Investigate the pathobiology of Tourette syndrome and related disorders by measuring various compounds of interest in cerebrospinal fluid, plasma, and urine of patients with Tourette syndrome, obsessive compulsive disorder, and/or chronic tics.
II. Determine the pattern of familial aggregation of Tourette syndrome and obsessive compulsive disorder by systematic assessment of all first-degree family members of patients selected for cerebrospinal fluid studies.
III. Establish the neurochemical and neuropeptide profile associated with the range of expression of the putative Tourette gene expression in adult and adolescent patients.
Detailed description
PROTOCOL OUTLINE: All patients are screened with a complete physical and neurologic exam, and a semi-structured interview. Patients then receive a comprehensive assessment of systemic disease. Patients and first-degree family members also participate in a genetic study.
Any patient who experiences an unusual exacerbation of symptoms or significant side effects is removed from the study.
Study design
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
- Background: PubMed 10356639van Wattum PJ, Anderson GM, Chappell PB, Goodman WK, Riddle MA, Leckman JF. Cerebrospinal fluid dynorphin A[1-8] and beta-endorphin levels in Tourette's syndrome are unaltered. Biol Psychiatry. 1999 Jun 1;45(11):1527-8. doi: 10.1016/s0006-3223(98)00313-8. No abstract available.
- Background: PubMed 9861477Peterson BS, Leckman JF. The temporal dynamics of tics in Gilles de la Tourette syndrome. Biol Psychiatry. 1998 Dec 15;44(12):1337-48. doi: 10.1016/s0006-3223(98)00176-0.
- Background: PubMed 9298805Cohen DJ, Leckman JF, Pauls D. Neuropsychiatric disorders of childhood: Tourette's syndrome as a model. Acta Paediatr Suppl. 1997 Jul;422:106-11. doi: 10.1111/j.1651-2227.1997.tb18357.x.
- Background: PubMed 8988803Rasmusson AM, Anderson GM, Lynch KA, McSwiggan-Hardin M, Scahill LD, Mazure CM, Goodman WK, Price LH, Cohen DJ, Leckman JF. A preliminary study of tryptophan depletion on tics, obsessive-compulsive symptoms, and mood in Tourette's syndrome. Biol Psychiatry. 1997 Jan 1;41(1):117-21. doi: 10.1016/s0006-3223(96)00380-0. No abstract available.
- Background: PubMed 8195454Peterson BS, Leckman JF, Scahill L, Naftolin F, Keefe D, Charest NJ, King RA, Hardin MT, Cohen DJ. Steroid hormones and Tourette's syndrome: early experience with antiandrogen therapy. J Clin Psychopharmacol. 1994 Apr;14(2):131-5.
- Background: PubMed 8731518Chappell P, Leckman J, Goodman W, Bissette G, Pauls D, Anderson G, Riddle M, Scahill L, McDougle C, Cohen D. Elevated cerebrospinal fluid corticotropin-releasing factor in Tourette's syndrome: comparison to obsessive compulsive disorder and normal controls. Biol Psychiatry. 1996 May 1;39(9):776-83. doi: 10.1016/0006-3223(95)00221-9.
- Background: PubMed 8080901Chappell P, Riddle M, Anderson G, Scahill L, Hardin M, Walker D, Cohen D, Leckman J. Enhanced stress responsivity of Tourette syndrome patients undergoing lumbar puncture. Biol Psychiatry. 1994 Jul 1;36(1):35-43. doi: 10.1016/0006-3223(94)90060-4.
- Background: PubMed 9861478Martin A, State M, Anderson GM, Kaye WM, Hanchett JM, McConaha CW, North WG, Leckman JF. Cerebrospinal fluid levels of oxytocin in Prader-Willi syndrome: a preliminary report. Biol Psychiatry. 1998 Dec 15;44(12):1349-52. doi: 10.1016/s0006-3223(98)00190-5.
- Background: PubMed 7766289Leckman JF, Goodman WK, Anderson GM, Riddle MA, Chappell PB, McSwiggan-Hardin MT, McDougle CJ, Scahill LD, Ort SI, Pauls DL, et al. Cerebrospinal fluid biogenic amines in obsessive compulsive disorder, Tourette's syndrome, and healthy controls. Neuropsychopharmacology. 1995 Feb;12(1):73-86. doi: 10.1038/sj.npp.1380241.
- Background: PubMed 2742727Riddle MA, Jatlow PI, Anderson GM, Cho SC, Hardin MT, Cohen DJ, Leckman JF. Plasma debrisoquin levels in the assessment of reduction of plasma homovanillic acid. The debrisoquin method. Neuropsychopharmacology. 1989 Jun;2(2):123-9. doi: 10.1016/0893-133x(89)90015-8.
- Background: PubMed 2304369Anderson GM, Mefford IN, Tolliver TJ, Riddle MA, Ocame DM, Leckman JF, Cohen DJ. Serotonin in human lumbar cerebrospinal fluid: a reassessment. Life Sci. 1990;46(4):247-55. doi: 10.1016/0024-3205(90)90030-u.
- Background: PubMed 1699245Leckman JF, Goodman WK, Riddle MA, Hardin MT, Anderson GM. Low CSF 5HIAA and obsessions of violence: report of two cases. Psychiatry Res. 1990 Jul;33(1):95-9. doi: 10.1016/0165-1781(90)90152-u. No abstract available.
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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.
James F. Leckman study chair
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourette Syndrome and Obsessive Compulsive Disorder, run by National Center for Research Resources (NCRR) 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?
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 24 Jun 2005. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004325, which also lists 22 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 24 Jun 2005.