Anorexia NervosaNCT00004550
Evaluation and Follow-up of Individuals With Obsessive-Compulsive Disorder and Related Conditions
An observational study of Anorexia Nervosa and Obsessive Compulsive Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to better understand the long-term progress of people with obsessive-compulsive disorder (OCD) and related conditions such as anorexia nervosa, Tourette syndrome, and trichotillomania. This study involves the screening and follow-up of individuals with OCD and OCD-related disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia Nervosa, Obsessive Compulsive Disorder, Tourette Syndrome
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2000to 21 Apr 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals must fulfill DSM IV criteria for OCD or OCD-related disorders as determined by a complete psychiatric diagnostic interview (SCID-I, using DSM IV-TR).
- Individuals must be capable of decision making, and able to comprehend the purpose of the study and to provide informed consent.
- Individuals can be included if they have certain medical conditions that have been described to have a higher incidence of OCD/depression and anxiety disorders: e.g., individuals with underlying neurological or neuropsychiatric conditions (e.g., tic disorders or dystonias, including torticollis and blepharospasm), connective tissue disorders, but must show no other serious or acute medical illnesses as determined by a physical exam and standard laboratory examinations.
- Individuals must be at least 18 years old.
Who cannot join
- Alcohol or substance use or dependence of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups).
- Current history of aggressive behavior or current suicidal ideation with plan and intent.
- Current active psychosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Evaluation and Follow-up of Patients With Obsessive-Compulsive Disorder and OC Spectrum Disorders
The purpose of this study is to better understand the long-term progress of people with obsessive-compulsive disorder (OCD) and related conditions such as anorexia nervosa, Tourette syndrome, and trichotillomania.
This study involves the screening and follow-up of individuals with OCD and OCD-related disorders. Participants will be screened with a medical and psychiatric evaluation, questionnaires, and neurological testing. Participants will then have study visits every 4 to 12 weeks to undergo symptom and daily functioning evaluations, personality tests, blood and urine tests, memory tests, brain scans, and other clinical exams. Participants will be assessed with interviews and paper-and-pencil or computer-assisted tests. Participants may have the opportunity to participate in drug studies and to join a monthly OCD support group. At the end of the study, participants will be referred to community or private treatment centers.
Read the detailed description
The purpose of this protocol is to allow for careful screening and follow-up of patients with obsessive-compulsive disorder (OCD) and OCD-related disorders for a variety of protocols, recording demographic and rating information over the long-term course of the OCD illness and associated anxiety and depression symptoms. Patients in this study will be asked to participate in the naturalistic baseline assessment phase to better understand the pathophysiology and long-term course of illness. As a part of this protocol, subjects will be systematically administered assessment measures including diagnostic and psychological screening tests, a psychiatric assessment, SCID I and SCID II interviews, as well as other rating scales. They will also be informed of their opportunity to participate in research procedures such as blood draws and MRI of the brain. Upon conclusion of their participation, they will be referred out to community/private treatment when appropriate. All will be offered participation in an ongoing support group. This protocol will serve as an entry point for individuals with OCD and OCD-related disorders to proceed into other investigation procedures.
- Keywords
- Screening, Longitudinal, Transition, Treatment, Comorbidity, Obsessive Compulsive Disorder, Evaluation, Follow-Up, OC Spectrum Disorders, OCD
- Medical subject headings
- Anorexia Nervosa, Obsessive-Compulsive Disorder, Tourette Syndrome, Trichotillomania
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2000 (estimated)
- Study start28 Jan 2000
- Study completion21 Apr 2008
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 Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Observational
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004550
- Sponsor's protocol ID
- 000067
- Other IDs
- 00-M-0067
- Status last verified
- 21 Apr 2008
- First submitted
- 3 Feb 2000
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Wiggs CL, Martin A, Altemus M, Murphy DL. Hypervigilance in patients with obsessive-compulsive disorder. Anxiety. 1996;2(3):123-9. doi: 10.1002/(SICI)1522-7154(1996)2:33.0.CO;2-Q.
PubMed 9160613
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation and Follow-up of Patients With Obsessive-Compulsive Disorder and OC Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00004550
- Acronym / sponsor ID
- 000067
- Keywords
- Screening, Longitudinal, Transition, Treatment, Comorbidity, Obsessive Compulsive Disorder, Evaluation, Follow-Up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 28 Jan 2000
- Study completion
- 21 Apr 2008
- First posted
- 4 Feb 2000 (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 better understand the long-term progress of people with obsessive-compulsive disorder (OCD) and related conditions such as anorexia nervosa, Tourette syndrome, and trichotillomania.
This study involves the screening and follow-up of individuals with OCD and OCD-related disorders. Participants will be screened with a medical and psychiatric evaluation, questionnaires, and neurological testing. Participants will then have study visits every 4 to 12 weeks to undergo symptom and daily functioning evaluations, personality tests, blood and urine tests, memory tests, brain scans, and other clinical exams. Participants will be assessed with interviews and paper-and-pencil or computer-assisted tests. Participants may have the opportunity to participate in drug studies and to join a monthly OCD support group. At the end of the study, participants will be referred to community or private treatment centers.
Detailed description
The purpose of this protocol is to allow for careful screening and follow-up of patients with obsessive-compulsive disorder (OCD) and OCD-related disorders for a variety of protocols, recording demographic and rating information over the long-term course of the OCD illness and associated anxiety and depression symptoms. Patients in this study will be asked to participate in the naturalistic baseline assessment phase to better understand the pathophysiology and long-term course of illness. As a part of this protocol, subjects will be systematically administered assessment measures including diagnostic and psychological screening tests, a psychiatric assessment, SCID I and SCID II interviews, as well as other rating scales. They will also be informed of their opportunity to participate in research procedures such as blood draws and MRI of the brain. Upon conclusion of their participation, they will be referred out to community/private treatment when appropriate. All will be offered participation in an ongoing support group. This protocol will serve as an entry point for individuals with OCD and OCD-related disorders to proceed into other investigation procedures.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals must fulfill DSM IV criteria for OCD or OCD-related disorders as determined by a complete psychiatric diagnostic interview (SCID-I, using DSM IV-TR).
- Individuals must be capable of decision making, and able to comprehend the purpose of the study and to provide informed consent.
- Individuals can be included if they have certain medical conditions that have been described to have a higher incidence of OCD/depression and anxiety disorders: e.g., individuals with underlying neurological or neuropsychiatric conditions (e.g., tic disorders or dystonias, including torticollis and blepharospasm), connective tissue disorders, but must show no other serious or acute medical illnesses as determined by a physical exam and standard laboratory examinations.
- Individuals must be at least 18 years old.
Key exclusion criteria (3 listed)
- Alcohol or substance use or dependence of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups).
- Current history of aggressive behavior or current suicidal ideation with plan and intent.
- Current active psychosis.
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 2 Jul 2017.
- Background: PubMed 9160613Wiggs CL, Martin A, Altemus M, Murphy DL. Hypervigilance in patients with obsessive-compulsive disorder. Anxiety. 1996;2(3):123-9. doi: 10.1002/(SICI)1522-7154(1996)2:33.0.CO;2-Q.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anorexia Nervosa and Obsessive Compulsive Disorder, run by National Institute of Mental Health (NIMH) 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 4 inclusion and 3 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 2 Jul 2017. 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 NCT00004550, 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 2 Jul 2017.