PSYCHIATRIC MISDIAGNOSES:
No one who has Lyme can be diagnosed as
"Bipolar." The same is true for
Multiple Sclerosis. MS is a
rule-out for Bipolar according to the
DSM-IV.
Lyme is a brain disease, so no one
with Lyme can be diagnosed with anything
"psychiatric" and all Lyme victims
should stay away from psychiatrists.
From the text of the NIH Clinical
Trial below:
"4. Needlestick to collect 3
tablespoons of blood to measure blood
count and thyroid levels, liver and
kidney function, to test the immune
system and check for certain diseases,
such as Lyme disease."
See- Brian
Fallon @ www.columbia-lyme.org
This is a published chapter in the
Sadock's 2002 Comprehensive Textbook of
Psychiatry.
Ruling out Lyme disease in Bipolar
disorder in children and Adolescents:
http://www.clinicaltrials.gov/ct/gui/show/NCT00006177?order=1
- Study ID Numbers 000198;
00-M-0198
Symptoms and
Causes of Bipolar Disorder in Children
and Adolescents
This
study is currently recruiting patients.
Sponsored by
-
National Institute of Mental Health (NIMH)
Purpose
The purpose of this study is to
learn more about and describe the
moods and behaviors of children with
bipolar disorder. This study will also
examine what happens in the brain to
produce these moods and behaviors.
This is not a treatment study;
children will not receive any new or
experimental therapies
Children and adolescents ages 6
through 17 with bipolar disorder and
normal healthy volunteers (controls)
of the same age group may participate
in this study. Candidates will have a
telephone interview and review of
medical records to determine
eligibility. Additional screening will
include a medical and psychiatric
history of the patient and extended
family members, and a physical and
neurological evaluation. The medical
history interviews will be videotaped
and kept confidential.
Study participants will have a
3-day baseline evaluation, including
the following physiologic tests and
procedures:
1. Questionnaires and interviews
about the subject's mood and behavior,
stressful family events, and so forth,
and observation and documentation of
the subject's behavior twice daily by
clinical staff.
2. Computer and written tests to
assess intelligence, memory, learning,
motor skills, reaction time, and
planning skills.
3. Tests to measure heart rate,
sweating, brain wave activity and
eyeblinking while watching film clips
that elicit various emotions and while
playing computer games. Recordings
include electromyogram,
electrooculogram, heart rate, skin
conductance, and electroencephalogram.
4. Needlestick to collect 3
tablespoons of blood to measure blood
count and thyroid levels, liver and
kidney function, to test the immune
system and check for certain diseases,
such as Lyme
disease.
5. Magnetic resonance imaging (MRI)
of the brain.
When the baseline evaluation is
completed, the subject will return
home for a 28-day period of "at-home
observation." The subject and parent
will complete daily questionnaires,
and a NIMH staff member will observe
the patient's behavior at home and at
school for 2 days during this period.
The observations will be videotaped
and kept confidential.
At the end of the at-home
observations, the subject and parent
will return to the clinic for a 2-day
evaluation that will include
questionnaires, repeat physiologic
tests described above, and a urine
sample to check for drugs.
After this evaluation, control
subjects will have completed their
participation in the study. Follow-up
evaluations will be scheduled for
patients only as follows: at the end
of 2 months, then every 3 months until
a year has passed from the first
visit, then every 6 months for 4
years. Some visits will involve only
interviews and questionnaires, some
will also include a physical exam, and
urine test and others will also
include a blood tests. A MRI brain
scan will be done at 2 and 4 years.
Patients, their parents and
siblings will also be asked to have
blood drawn to obtain a DNA sample for
genetic studies.
| Condition
|
- Bipolar Disorder
- Healthy
|
MEDLINEplus related topics: Bipolar Disorder
Study
Type: Observational
Study Design: Natural History
Official Title: The
Phenomenology and Neurophysiology of
Affective Dysregulation in Children and
Adolescents with Bipolar Disorder
Further Study Details:
Families who are interested in
participating receive an extensive
telephone interview and those who are
judged to be likely to meet inclusion
criteria are invited to the NIMH.
There, study participants have a 5-day
baseline evaluation, including
physiologic tests and procedures,
neuropsychological testing, and
questionnaires and interviews about
mood and behavior. In addition, staff
members obtain a medical and
psychiatric history of the patient and
extended family members, and a
physical and neurological evaluation.
Participants are asked to perform
computer and written tests to assess
intelligence, memory, learning, motor
skills, reaction time, and planning
skills. Psychophysiological measures
(such as heart rate, skin conductance,
and electroencephalogram) are obtained
in response to emotions and while
playing computer games. Participants
are asked to give blood samples for
blood count and thyroid levels, liver
and kidney function and to check for
other diseases. Structural magnetic
resonance imaging (MRI) scans of the
brain are obtained.
After baseline evaluation,
participants return home for a 28-day
period of "at-home observation."
Participants and parents complete
brief daily questionnaires and
participants wear an activity monitor
on their wrist. Participants and
parents then return to the NIH for
repeat evaluations and physiologic
tests after 2 months, and then every 3
months until 12 months have passed
from the first visit. Thereafter,
visits are every 6 months for 4 years.
Some visits will involve only
interviews and questionnaires, some
will also include a physical exam,
blood tests, and urine tests. Repeated
MRI brain scan will be done at 2 and 4
years. Patients, their parents and
siblings will also be asked to have
blood drawn to obtain a DNA sample for
genetic studies.
All tests and procedures are
provided free of charge, and travel
expenses are paid by the NIMH.
Eligibility
Genders Eligible for Study:
Both
Accepts Healthy Volunteers
Criteria
- BIPOLAR PATIENTS:
- Boys and girls must be ages 6-17
and meet DSM-IV criteria for bipolar
disorder.
- The child must have a primary
caregiver who can accompany him or her
on trips to NIMH, provide reliable
history information, and complete
daily rating scales and sleep logs.
- Patients must have a psychiatrist
who provides clinical care for their
Bipolar Disorder.
- All youth accepted into the study
must be able to complete self-rating
forms and to cooperate with other
study procedures.
- Subjects must be on a stable
medication regimen for at least 14
days prior to enrollment in the study.
In addition, they, their parents, and
treating physician must agree to keep
medications stable (with the exception
of minor dosage adjustments) until the
end of the second NIMH evaluation, if
clinically feasible and acceptable.
The total duration of the
medication-stable period will be
approximately six weeks.
- Patients must have an I.Q. greater
than or equal to 70.
- Patients must not have autistic
disorder or severe pervasive
developmental disorder.
- Patients must not have psychosis
that interferes with the child's
capacity to understand and comply with
study procedures.
- Patients must not have an unstable
medical illness (e.g., severe asthma).
- Patients must not have a medical
illness that could cause the symptoms
of bipolar illness (e.g., multiple
sclerosis, thyroid disease).
- Patients must not be pregnant.
- Patients must not have engaged in
substance abuse within two months of
the initial evaluation.
- CONTROLS:
- Healthy normal volunteers.
- Control subjects will be age- and
sex- matched to the patients.
- They will have normal physical and
neurological examinations, and an
identified primary care physician.
- Both control subjects and their
first-degree relatives must be free of
current or past psychopathology.
- Controls must have an I.Q. greater
than or equal to 70.
- Controls must not have ongoing
medical illness.
- Controls must not have neurologic
disorder (including seizures).
- Controls must not be pregnant.
- Controls must not have engaged in
past or present substance abuse.
- Controls must not have a history
of sexual abuse.
Expected Total Enrollment:
400
Location and Contact
Information
- Maryland
-
- National Institute of Mental
Health (NIMH), 9000 Rockville Pike,
Bethesda, Maryland,
20892, United
States; Recruiting
-
- Patient
Recruitment and Public Liaison
Office 1-800-411-1222
prpl@mail.cc.nih.gov
- TTY
1-866-411-1010
More Information
Detailed Web Page
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.
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.
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. Review.
- Study ID Numbers 000198;
00-M-0198
-
- Study Start Date August 9, 2000
- Record last reviewed July
30, 2002
- Last Updated July 30, 2002
- NLM Identifier
NCT00006177
- ClinicalTrials.gov processed this
record on 2003-05-01