Tourette's DisorderNCT01315327
Omega-3 Fatty Acids in Tourette's Disorder
A study testing Omega-3 Fatty Acids and Olive oil in people with Tourette's Disorder, run by NYU Langone Health at 1 site in United States.
Trial summary
This study examines the safety and efficacy of omega-3 fatty acids (fish oil) for the treatment of Tourette's Disorder. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Tourette's Disorder
- What is being tested?
- Omega-3 Fatty Acids and Olive oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to May 2012
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 6 through 18 inclusive
- Meet full DSM-IV diagnostic criteria for TD or chronic motor tic disorder
- Normal laboratory results, including serum chemistries, hematology, and urinalysis
- Must be able to swallow capsules.
- Must be of normal intelligence in the judgment of the investigator.
- Subjects and parents must possess an educational level, degree of understanding and command of the English language to enable them to communicate suitably with the investigator and study coordinator and to understand the nature of the study.
- Subjects and their legal representatives must be considered reliable.
Who cannot join
- Organic brain disease, for example, traumatic brain injury residua
- Meeting criteria for mental retardation as defined by the DSM-IV.
- A history of seizure disorder (other than febrile seizure).
- A Subjects with history of Sydenham's Chorea.
- Autism, schizophrenia or other psychotic disorders.
- A primary diagnosis of a major mood disorder that requires ongoing psychiatric treatment.
Show all 11Show fewer
- A neurological disorder other than a tic disorder.
- A documented auto-immune disorder.
- A major medical illness.
- A history of ongoing or previously undisclosed child abuse (risk of removal from home would not allow for consistent caretaker ratings).
- Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Study of Omega-3 Fatty Acids in Children and Adolescents With Tourette's Disorder
This study examines the safety and efficacy of omega-3 fatty acids (fish oil) for the treatment of Tourette's Disorder.
Read the detailed description
This is a 20-week, double-blind, placebo (olive oil) controlled study examining supplemental fish oil in the treatment of tic and OCD symptoms.
- Conditions
- Tourette's Disorder
- Being tested
- Omega-3 Fatty Acids, Olive oil
- Keywords
- Tourette's Disorder, Obsessive-Compulsive Disorder, tics
- Medical subject headings
- Tourette Syndrome, Obsessive-Compulsive Disorder, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidsDrug
Omega-3 fatty acids (derived from fish oil)
Olive oilDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Fatty Acids | Experimental | Omega-3 Fatty Acids (fish oil), flexibly titrated up to 6000 mg/day. Receives: Drug: Omega-3 Fatty Acids |
| Placebo | Placebo comparator | Olive oil placebo, looks and tastes identical to active intervention. Receives: Drug: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Global Tic Severity Scale (YGTSS)
This assessment captures tic type and frequency as well as intensity and complexity, and impairment due to tics.
Measured: Baseline and then weekly for 20 weeks
Secondary outcomes (1)
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Assesses type, frequency, and impairment of obsessions and compulsions
Measured: Baseline and then weekly for 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMay 2003
- Primary completionFeb 2006
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette's DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Tourette Association of America
- Responsible party
- Sponsor
- Investigators
- Vilma Gabbay, MD, MS, Principal investigator, NYU School of MedicineBarbara J Coffey, MD, MS, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315327
- Sponsor's protocol ID
- TSA Omega-3
- Status last verified
- Jun 2014
- First submitted
- 11 Mar 2011
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gabbay V, Babb JS, Klein RG, Panzer AM, Katz Y, Alonso CM, Petkova E, Wang J, Coffey BJ. A double-blind, placebo-controlled trial of omega-3 fatty acids in Tourette's disorder. Pediatrics. 2012 Jun;129(6):e1493-500. doi: 10.1542/peds.2011-3384. Epub 2012 May 14.
PubMed 22585765
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of Omega-3 Fatty Acids in Children and Adolescents With Tourette's Disorder
- ClinicalTrials.gov ID
- NCT01315327
- Acronym / sponsor ID
- TSA Omega-3
- Conditions
- Tourette's Disorder
- Keywords
- Tourette's Disorder, Obsessive-Compulsive Disorder, tics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Tourette Association of America
- Study start
- May 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Mar 2011 (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 examines the safety and efficacy of omega-3 fatty acids (fish oil) for the treatment of Tourette's Disorder.
Detailed description
This is a 20-week, double-blind, placebo (olive oil) controlled study examining supplemental fish oil in the treatment of tic and OCD symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Fatty Acids | Experimental | Drug: Omega-3 Fatty AcidsOmega-3 Fatty Acids (fish oil), flexibly titrated up to 6000 mg/day. |
| Placebo | Placebo comparator | Drug: Olive oilOlive oil placebo, looks and tastes identical to active intervention. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Ages 6 through 18 inclusive
- Meet full DSM-IV diagnostic criteria for TD or chronic motor tic disorder
- Normal laboratory results, including serum chemistries, hematology, and urinalysis
- Must be able to swallow capsules.
- Must be of normal intelligence in the judgment of the investigator.
Key exclusion criteria (11 listed)
- Organic brain disease, for example, traumatic brain injury residua
- Meeting criteria for mental retardation as defined by the DSM-IV.
- A history of seizure disorder (other than febrile seizure).
- A Subjects with history of Sydenham's Chorea.
- Autism, schizophrenia or other psychotic disorders.
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 |
|---|---|---|
| Omega-3 Fatty AcidsOmega-3 fatty acids (derived from fish oil) | Drug | Omega-3 Fatty Acids |
| Olive oilPlacebo | Drug | Placebo |
Primary outcome
Yale Global Tic Severity Scale (YGTSS)
Time frame: Baseline and then weekly for 20 weeks
This assessment captures tic type and frequency as well as intensity and complexity, and impairment due to tics.
1 secondary outcome
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time frame: Baseline and then weekly for 20 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 Jul 2014.
- Results publication: PubMed 22585765Gabbay V, Babb JS, Klein RG, Panzer AM, Katz Y, Alonso CM, Petkova E, Wang J, Coffey BJ. A double-blind, placebo-controlled trial of omega-3 fatty acids in Tourette's disorder. Pediatrics. 2012 Jun;129(6):e1493-500. doi: 10.1542/peds.2011-3384. Epub 2012 May 14.
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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.
Vilma Gabbay, MD, MS principal investigator
NYU School of Medicine
Barbara J Coffey, MD, MS principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acids and Olive oil in people with Tourette's Disorder, run by NYU Langone Health 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 7 inclusion and 11 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 Jul 2014. 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.
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?
Yale Global Tic Severity Scale (YGTSS) (time frame: Baseline and then weekly for 20 weeks). 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 NCT01315327, which also lists 1 linked publication.
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 Jul 2014.