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Bipolar DisorderNCT00006177

Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study

An observational study of Bipolar Disorder and Mood Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This research protocol seeks to learn more about bipolar disorder in children and adolescents ages 6-17. Researchers will describe the moods and behaviors of children with bipolar disorder and use specialized testing and brain imaging to learn about specific brain changes associated with the disorder. Read more about this study

Who is it for?
Ages 3 to 58 years
How many people
1,303 participants
Where
1 siteUnited States
Study dates
11 Aug 2000to 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 3 to 58 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: There are 11 separate populations being studied in this protocol: 1. Children and adolescents between the ages of 6-17 years old who meet criteria for BSD. 2. Adults between the ages of 18-58 years old who meet criteria for BD, including those age 18-25 with BSD. 3. Control populations of: a) Healthy volunteer children and adolescents between the ages of 3-17 years old, b) Parents of healthy volunteer children or healthy adults in research, c) Children 8-17 years old with attention deficit hyperactivity disorder (ADHD), who do not have a mood disorder. 4. First and second-degree biological relatives of those in (B.1) or (B.2), above, and are between 3-58 years old. 5. A subgroup of these cohorts will be Old Order Amish individuals who fulfill eligibility for (1), (2), (3a), (3b), or (4).

Who may be able to join

  • Inclusion and exclusion criteria for each group are outlined below. The total accrual ceiling is 2050, including subjects of both sexes, made up of the following 11 populations:
  • Pediatric patients with bipolar disorder or SMIBRD:
  • Age 6-17
  • Meet DSM criteria for BD
  • Have a primary caregiver who can accompany him or her on trips to NIMH and provide reliable history and information.
  • Have a psychiatrist who provides clinical care for their BSD.
Show all 38Show fewer
  • Be able to complete self-rating forms and to cooperate with other study procedures.
  • DSM Bipolar Disorder
  • Age 18-58
  • Be able to complete self-rating forms and to cooperate with other study procedures.
  • Medically safe to perform MRI
  • Age- and sex- matched to the bipolar patients.
  • Have an identified primary care physician.
  • Speaks English
  • For healthy adults (not parents): Healthy adults age 25-58
  • For parents of healthy volunteers: Parents of control subjects as outlined in B above
  • Age 25-58
  • Speaks English
  • Age 8-17
  • Currently meets DSM-IV criteria for ADHD
  • t score >65 on the Connors Parent scales
  • Subjects with other psychiatric disorders including anxiety disorders, dysthymic disorder, past major depression, oppositional defiant disorder, tic disorders, and the learning, communication, and elimination disorders may be accepted
  • First degree relatives (parent or sibling) or second-degree relative (grandparent, grandchild, uncle, aunt, nephew, niece, half-sibling) of patients with BD
  • Age 3-58
  • Age 8-17
  • Meet DSM-IV criteria for BD
  • Have a primary caregiver who can provide a reliable history
  • Be able to complete self-rating forms and to cooperate with other study procedures.
  • DSM-IV Bipolar Disorder
  • Age 18-58
  • Be able to complete self-rating forms and to cooperate with other study procedures.
  • Age 8-17
  • Parent or sibling (first-degree relative) diagnosed with BD
  • Age 8-17
  • No serious physical or neurological symptoms or disorder by history
  • Age 18-58
  • No serious physical or neurological symptoms or disorder by history
  • For Parents of child with BD or spouses of patient with BD: Spouse or offspring with BD

Who cannot join

  • I.Q. < 70
  • Autistic disorder or more than mild autism spectrum disorder;
  • Psychosis that interferes with the child s capacity to understand and comply with study procedures
  • Unstable medical illness (e.g. severe asthma)
  • Medical illness that could cause the symptoms of BSD (e.g. multiple sclerosis, thyroid disease)
  • Pregnancy
Show all 108Show fewer
  • Substance abuse within two months of the initial evaluation, since alcohol and abused substances interfere with interpretation of fMRI and cognitive task data.
  • NIMH IRP Employee family member
  • Adults with BD participating as individuals or as parents of at- risk children:
  • Diagnosis of schizophrenia or other current psychosis.
  • Claustrophobia or anxiety that prevents participation in MRI
  • Any serious medical illness, such as heart, liver, or kidney disease.
  • A history of drug or alcohol abuse in the past 90 days.
  • Current or past seizure disorder
  • Currently unstable hyperthyroidism or hypothyroidism
  • Currently receiving medical treatment that would affect mood, such as steroids
  • Pregnant or breast-feeding.
  • Active suicidal or homicidal thoughts or plans
  • NIMH IRP Employee/family member
  • Healthy volunteer children and adolescents:
  • I.Q. < 70
  • Any serious medical condition or condition that interferes with fMRI scanning
  • Pregnancy
  • Past or current diagnosis of any anxiety disorder (panic disorder, GAD, Separation Anxiety Disorder, Social Phobia), mood disorder (manic or hypomanic episode, major depression), OCD, PTSD, Conduct Disorder, psychosis, current suicidal ideation, Tourette
  • Disorder, Autism Spectrum Disorder or ADHD.
  • Substance abuse within two months prior to study participation or present substance abuse
  • History of sexual abuse.
  • Parent or sibling with Bipolar Disorder, recurrent MDD, or any disorder with psychosis.
  • NIMH IRP Employee family member
  • Parents of healthy volunteer children (Amish and Non-Amish) and Healthy Adults (not parents):
  • IQ< 70
  • Any current psychiatric diagnosis
  • NIMH IRP Employee/family member
  • Control subjects with ADHD but not BD:
  • IQ<70
  • Pregnancy
  • Ongoing medical illness or neurological disorder other than ADHD
  • Any condition that would interfere with the participants ability to perform fMRI or other research tasks
  • Current Major Depression
  • Any past or present manic or hypomanic episode.
  • NIMH IRP Employee family member
  • First- and Second-degree relatives of patients with BD:
  • Active psychosis
  • Dementia
  • IQ < 70
  • Any clinical condition in need of immediate care
  • Any chronic medical illness resulting in impaired CNS function
  • Any condition that interferes with the participants ability to perform research tasks
  • NIMH IRP Employee/family member
  • Amish Community children with BD:
  • IQ<70
  • Active psychosis
  • Any clinical condition in need of immediate care
  • Any chronic medical illness resulting in impaired CNS function
  • Any condition that would interfere with the participants ability to perform behavioral research tasks
  • Limitations with English that would interfere with understanding consent/assent, interview, or task instructions.
  • NIMH IRP Employee family member
  • Amish Community Adults with BD:
  • Diagnosis of schizophrenia or other current psychosis.
  • Any serious medical illness, such as heart, liver, or kidney disease.
  • A history of drug or alcohol abuse in the past 90 days.
  • Current or past seizure disorder
  • Currently unstable hyperthyroidism or hypothyroidism
  • Currently receiving medical treatment that would affect mood, such as steroids
  • Active suicidal or homicidal thoughts or plans
  • Limitations with English that would interfere with understanding consent/assent, interview, or task instructions.
  • NIMH IRP Employee/family member
  • Amish Community at-risk subjects:
  • IQ<70
  • Active psychosis
  • Any clinical condition in need of immediate care
  • Any chronic medical illness resulting in impaired CNS function
  • Any condition that would interfere with the participants ability to perform behavioral research tasks
  • Limitations with English that would interfere with understanding consent/assent, interview, or task instructions.
  • NIMH IRP Employee family member
  • Amish Community healthy volunteer children \& adolescents:
  • I.Q. < 70
  • Ongoing medical illness
  • Neurological disorder (including seizures)
  • Past or present substance abuse
  • History of sexual abuse
  • Limitations with English that would interfere with understanding consent/assent, interview or task instructions
  • Past or present psychopathology in control subject or their first-degree relative
  • NIMH IRP Employee family member
  • Amish Community adults who are parents of healthy volunteer children \& adolescents, healthy spouses of Amish adults with BD, or parents of adolescents with BD:
  • I.Q. < 70
  • Ongoing medical illness
  • Neurological disorder (including seizures)
  • Past or present substance abuse
  • History of sexual abuse
  • Limitations with English that would interfere with understanding consent/assent, interview or task instructions
  • NIMH IRP Employee/family member
  • For Healthy volunteers: Past or present psychopathology in participant or their first-degree relative
  • For Parents of healthy volunteer children: Past or present psychopathology as in (4) above.
  • In addition, children with BD (Section B.1.) who wish to receive treatment, including discontinuation of medication while inpatients on the pediatric behavioral health unit at NIH, may be eligible for treatment if they meet the following additional criteria:
  • All inclusion criteria for B.1 (above)
  • Treatment failure as defined by current CGAS score <60
  • The child s psychiatrist/treating physician agrees that a change in medication regimen is appropriate
  • All exclusion criteria for B.1 (above)
  • Any contraindications for MRI scanning, plus claustrophobia or extreme separation anxiety
  • EXCLUSIONS for MRI Scanning:
  • Pregnancy
  • Substance abuse within two months of the initial evaluation, since alcohol and abused substances interfere with interpretation of fMRI and cognitive task data.
  • Claustrophobia or anxiety that prevents participation in MRI
  • Any serious medical condition or condition that interferes with fMRI scanning
  • Metal in body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if you were a welder or metal worker, since there may be
  • small metal fragments in the eye
  • Unable to lie comfortably on back for up to 90 minutes

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: The Phenomenology and Neurophysiology of Affective Dysregulation in Children and Adolescents With Bipolar Disorder

This research protocol seeks to learn more about bipolar disorder in children and adolescents ages 6-17. Researchers will describe the moods and behaviors of children with bipolar disorder and use specialized testing and brain imaging to learn about specific brain changes associated with the disorder. This protocol studies children who have been diagnosed with bipolar disorder, and those who have a sibling or parent with bipolar disorder and are thus considered "at risk" for developing the disorder.

Read the detailed description

Objective:

For this protocol we define Bipolar Spectrum disorders (BSD) as the propensity to have a manic episode by having Bipolar Disorder or Substance/Medication-Induced Bipolar and Related Disorder. BSD in children and adolescents is receiving increased research attention, but important questions remain about its developmental trajectory, phenomenology and behavioral correlates, and little is known about its underlying neural mechanisms. In its study of youth with BSD, this study has three objectives:

  1. to use longitudinal techniques to characterize the clinical and physiological manifestations of pediatric BSD, and to use cross-sectional techniques (e.g., comparing children and adults with BSD on these measures) to provide preliminary data to guide such longitudinal studies
  2. to identify and follow longitudinally behavioral, neuropsychological, neurophysiological, and neuroanatomical correlates of pediatric BSD, and compare to children with chronic irritability and hyperarousal symptoms (severe mood dysregulation, SMD, as outlined in protocol 02-M-0021), youth with attention deficit hyperactivity disorder (ADHD), and typically developing youth.
  3. to examine genetic and familial correlates of pediatric BSD

Study population:

There are 11 separate populations being studied in this protocol:

  1. Children and adolescents between the ages of 6-17 years old who meet criteria for BSD.
  2. Adults between the ages of 18-58 years old who meet criteria for BD, including those age 18-25 with BSD.
  3. Control populations of: a) Healthy volunteer children and adolescents between the ages of 3-17 years old, b) Parents of healthy volunteer children or healthy adults in research, c) Children 8-17 years old with attention deficit hyperactivity disorder (ADHD), who do not have a mood disorder.
  4. First and second-degree biological relatives of those in (B.1) or (B.2), above, and are between 3-58 years old.
  5. A subgroup of these cohorts will be Old Order Amish individuals who fulfill eligibility for (1), (2), (3a), (3b), or (4).

Design:

For children and adolescents with BSD (i.e. Bipolar Disorder or those with Substance/Medication-Induced Bipolar and Related Disorder), this study is an outpatient characterization and longitudinal follow-along design. Once determined to be eligible, individuals come for an initial assessment, and then at varying intervals they return for clinical interviews, behavioral tasks, and structural and functional MRI.

For children and adolescents who are relatives of individuals with BSD, this is an outpatient follow-along design during which individuals come for an outpatient assessment and at 2-year intervals for clinical interviews, behavioral tasks, and structural and functional MRI.

For healthy volunteer children, children with only ADHD, adults with BD, and parents of healthy volunteer children, this study is an outpatient cross-sectional study that includes clinical interviews, behavioral tasks, and structural and functional MRI.

For all others, individuals come to NIH for clinical interviews, behavioral tasks, and MRI.

For most individuals in the Amish community, the investigation occurs in the field, where they receive clinical interviews and behavioral tasks. Some may choose to come to the NIH to participate in behavioral testing and MRI.

For all individuals, genetic material from saliva or blood is obtained under protocol 01-M-0254.

Outcome measures:

This study will examine between group differences in clinical, behavioral, genetic, neuroanatomical, and neurophysiological variables in individuals with BSD, their relatives, and healthy volunteers. Findings in children with BSD will also be compared to those with severe mood dysregulation, sometimes called a broad phenotype of pediatric BD, recruited under protocol 02-M-0021 (Nottelman, 2001).

Longitudinal clinical, behavioral, and neuroanatomical data will also be obtained.

Keywords
Emotion, Affective Neuroscience, Bipolar Disorder, Child, Child Bipolar, Natural History, BPD, Adolescent Bipolar
Medical subject headings
Bipolar Disorder, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00006177
Study groupRoleWhat they receive
Adult bipolar patientsAdult bipolar patients
Adult Extended Relatives of BD probandsAdult Extended Relatives of BD probands
Bipolar Children and YouthBipolar Children and Youth
Child/Adolescent Extended Relatives of BD probandsChild/Adolescent Extended Relatives of BD probands
Children with ADHD only (controls)Children with ADHD only (controls)
First degree relatives of BD patientsFirst degree relatives of BD patients
Healthy volunteer adults (parents or not)Healthy volunteer adults (parents or not)
Healthy volunteer children and youthHealthy volunteer children and youth

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective 1: clinical manifestations

    (1) clinical interviews [e.g., Schedule for Affective Disorders and Schizophrenia for School-Age Children-present and lifetime version, K-SADS-PL, (Kaufman et al., 1997); Structured Clinical Interview for DSM-IV-TR Axis I Disorders, SCID (First et al., 2002)]; (2) clinical and mood rating assessments (e.g., Children's Depression Rating Scale (Poznanski et al., 1984), Young Mania Rating Scale (Young et al., 1978), Pediatric Anxiety Rating (2002), EMA; (3) episode setting via detailed clinical interview at baseline and every 6 month follow up phone call (4) parent-report and self-report [e.g., The Screen for Child Anxiety Related Emotional Disorders SCARED (Birmaher et al., 1997); Social Responsiveness Scale, SRS (Constantino et al., 2003, Granader et al.); Child Behavior Checklist CBCL (Achenbach, 1991)].

    Measured: lifetime of protocol

  2. Objective 2: behavioral, neuropsychological, neurophysiological, and neuroanatomical correlates

    1. behavioral performance (e.g., accuracy, response time) on tasks assessing attention, emotion, and attention-emotion interactions; (e.g., Stop/Change task, CPT/Flanker, Decision Making tasks) 2) neuropsychological performance (e.g., performance and verbal IQ) 3) brain activation using functional MRI during tasks assessing attention, emotion, and attention-emotion interactions; 4) structural MRI to examine the size, shape and development of grey matter; 5) Diffusion Tensor Imaging (DTI) to measure white matter track myelination; 6) resting state imaging to test functional connectivity between prefrontal regions and the amygdala

    Measured: lifetime of protocol

  3. Objective 3: genetic and familial correlates

    (1) clinical interviews [e.g., Schedule for Affective Disorders and Schizophrenia for School-Age Children-present and lifetime version, K-SADS-PL, (Kaufman et al., 1997); Structured Clinical Interview for DSM-IV-TR Axis I Disorders, SCID (First et al., 2002)] to examine the rate of various diagnoses in relatives of individuals with BD (2) genetic material to compare genetic polymorphisms in BSD, their relatives and controls (3) relationship between genetic material and performance on behavioral tasks and activation during fMRI paradigms (4) behavioral performance on standardized paradigms; brain activation using functional MRI; size, shape and development of several ROIs using structural MRI; Diffusion Tensor Imaging (DTI); and, Resting State in individuals with a BD relative

    Measured: lifetime of protocol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2000 (estimated)
  2. Study start11 Aug 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006177
Sponsor's protocol ID
000198
Other IDs
00-M-0198
Status last verified
8 Mar 2023
First submitted
12 Aug 2000
Last updated
17 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: .We do not plan to make IDP available.

Publications

  • Geller B, Sun K, Zimerman B, Luby J, Frazier J, Williams M. Complex and rapid-cycling in bipolar children and adolescents: a preliminary study. J Affect Disord. 1995 Aug 18;34(4):259-68. doi: 10.1016/0165-0327(95)00023-g.

    PubMed 8550951

  • Wozniak J, Biederman J, Kiely K, Ablon JS, Faraone SV, Mundy E, Mennin D. Mania-like symptoms suggestive of childhood-onset bipolar disorder in clinically referred children. J Am Acad Child Adolesc Psychiatry. 1995 Jul;34(7):867-76. doi: 10.1097/00004583-199507000-00010.

    PubMed 7649957

  • Faedda GL, Baldessarini RJ, Suppes T, Tondo L, Becker I, Lipschitz DS. Pediatric-onset bipolar disorder: a neglected clinical and public health problem. Harv Rev Psychiatry. 1995 Nov-Dec;3(4):171-95. doi: 10.3109/10673229509017185.

    PubMed 9384947

  • Haller SP, Stoddard J, Cardenas SI, Dombek K, MacGillivray C, Botz-Zapp C, Bui HNT, Stavish CM, Kircanski K, Jones M, Brotman MA. Differentiating neural sensitivity and bias during face-emotion processing in youth: a computational approach. Soc Cogn Affect Neurosci. 2024 Jun 13;19(1):nsae034. doi: 10.1093/scan/nsae034.

    PubMed 38794949

  • Chen G, Taylor PA, Reynolds RC, Leibenluft E, Pine DS, Brotman MA, Pagliaccio D, Haller SP. BOLD Response is more than just magnitude: Improving detection sensitivity through capturing hemodynamic profiles. Neuroimage. 2023 Aug 15;277:120224. doi: 10.1016/j.neuroimage.2023.120224. Epub 2023 Jun 15.

    PubMed 37327955

  • Haller SP, Archer C, Jeong A, Jaffe A, Jones EL, Harrewijn A, Naim R, Linke JO, Stoddard J, Brotman MA. Changes in Internalizing Symptoms During the COVID-19 Pandemic in a Transdiagnostic Sample of Youth: Exploring Mediators and Predictors. Child Psychiatry Hum Dev. 2024 Feb;55(1):206-218. doi: 10.1007/s10578-022-01382-z. Epub 2022 Jul 6.

    PubMed 35794298

  • Zik J, Deveney CM, Ellingson JM, Haller SP, Kircanski K, Cardinale EM, Brotman MA, Stoddard J. Understanding Irritability in Relation to Anger, Aggression, and Informant in a Pediatric Clinical Population. J Am Acad Child Adolesc Psychiatry. 2022 May;61(5):711-720. doi: 10.1016/j.jaac.2021.08.012. Epub 2021 Aug 23.

    PubMed 34438022

  • Scheinost D, Dadashkarimi J, Finn ES, Wambach CG, MacGillivray C, Roule AL, Niendam TA, Pine DS, Brotman MA, Leibenluft E, Tseng WL. Functional connectivity during frustration: a preliminary study of predictive modeling of irritability in youth. Neuropsychopharmacology. 2021 Jun;46(7):1300-1306. doi: 10.1038/s41386-020-00954-8. Epub 2021 Jan 21.

    PubMed 33479511

  • Haller SP, Stoddard J, Pagliaccio D, Bui H, MacGillivray C, Jones M, Brotman MA. Computational Modeling of Attentional Impairments in Disruptive Mood Dysregulation and Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2021 May;60(5):637-645. doi: 10.1016/j.jaac.2020.08.468. Epub 2020 Nov 24.

    PubMed 33242544

  • Haller SP, Kircanski K, Stringaris A, Clayton M, Bui H, Agorsor C, Cardenas SI, Towbin KE, Pine DS, Leibenluft E, Brotman MA. The Clinician Affective Reactivity Index: Validity and Reliability of a Clinician-Rated Assessment of Irritability. Behav Ther. 2020 Mar;51(2):283-293. doi: 10.1016/j.beth.2019.10.005. Epub 2019 Nov 27.

    PubMed 32138938

  • Leibenluft E. Chronic irritability in children is not pediatric bipolar disorder: Implications for treatment. Bipolar Disord. 2020 Mar;22(2):195-196. doi: 10.1111/bdi.12881. Epub 2019 Dec 19. No abstract available.

    PubMed 31820531

  • Linke JO, Adleman NE, Sarlls J, Ross A, Perlstein S, Frank HR, Towbin KE, Pine DS, Leibenluft E, Brotman MA. White Matter Microstructure in Pediatric Bipolar Disorder and Disruptive Mood Dysregulation Disorder. J Am Acad Child Adolesc Psychiatry. 2020 Oct;59(10):1135-1145. doi: 10.1016/j.jaac.2019.05.035. Epub 2019 Jul 19.

    PubMed 31330239

  • Cardinale EM, Kircanski K, Brooks J, Gold AL, Towbin KE, Pine DS, Leibenluft E, Brotman MA. Parsing neurodevelopmental features of irritability and anxiety: Replication and validation of a latent variable approach. Dev Psychopathol. 2019 Aug;31(3):917-929. doi: 10.1017/S095457941900035X. Epub 2019 May 8.

    PubMed 31064595

  • Kryza-Lacombe M, Brotman MA, Reynolds RC, Towbin K, Pine DS, Leibenluft E, Wiggins JL. Neural mechanisms of face emotion processing in youths and adults with bipolar disorder. Bipolar Disord. 2019 Jun;21(4):309-320. doi: 10.1111/bdi.12768. Epub 2019 Apr 1.

    PubMed 30851221

  • Tseng WL, Deveney CM, Stoddard J, Kircanski K, Frackman AE, Yi JY, Hsu D, Moroney E, Machlin L, Donahue L, Roule A, Perhamus G, Reynolds RC, Roberson-Nay R, Hettema JM, Towbin KE, Stringaris A, Pine DS, Brotman MA, Leibenluft E. Brain Mechanisms of Attention Orienting Following Frustration: Associations With Irritability and Age in Youths. Am J Psychiatry. 2019 Jan 1;176(1):67-76. doi: 10.1176/appi.ajp.2018.18040491. Epub 2018 Oct 19.

    PubMed 30336704

Questions about this trial

What is this clinical trial studying?

An observational study of Bipolar Disorder and Mood Disorders, 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 38 inclusion and 108 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 17 Mar 2023. 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.

What does the primary outcome measure?

Objective 1: clinical manifestations (time frame: lifetime of protocol). The study lists 3 primary outcomes in all. 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 NCT00006177, which also lists 23 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 17 Mar 2023.

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