| Overview:
This is a brain imaging research study of posttraumatic stress disorder
(PTSD) with and without depression. Eligible participants receive
two brain positron emission tomography (PET) scans on one day
which assess the amounts of two proteins of the brain’s
serotonin system in various brain regions. A magnetic resonance
imaging (MRI) scan is also obtained, and there are interviews
and rating scales that are part of the study. Participants also
receive a test of the stress system known as the low dose dexamethasone
test. Up to 6 months of outpatient treatment is offered to participants
in the study at no cost. Also, participants may be compensated
$350 for time and inconvenience
Eligibility:
- Between18
and 65 years of age
- Meets
criteria for PTSD
- Not on current working medication regimen
Benefits
to participant:
- This study may benefit the subjects by offering them a thorough
medical and psychiatric work-up. Patients will be eligible
for up to 6 months of free treatment with therapy and/or medication.
For
more information about participating,
or if you have questions about the study, please contact:
Brendan
Carroll, BA
Phone:
212-543-5902
You will be asked several screening questions over the telephone to help determine if you may be eligible for the study.
Study
FAQs (Frequently Asked Questions):
1. What do I need to do
to participate?
Complete an initial phone screen and then an in-person screen
to verify your eligibility.
2. Is compensation provided for the
screening process?
No, you will not be compensated for the phone screen or the in-person
screen.
3. How long would I have to wait to receive
compensation?
Compensation is received as a check 4 to 6 weeks after PET.
4. What risks are involved?
Arterial Catheter: Before the brain imaging scans, an arterial
catheter will be placed in your arm and may cause mild discomfort.
There is a very small chance of complication from the catheter,
including bleeding, infection, cutting off of circulation to
the hand and blood clot.
PET Scan: During the PET scan, you will be exposed to low levels
of radiation. Although health hazards from such low levels have
never been shown, radiation risk is cumulative over a lifetime,
and additional exposure should be carefully considered. Everyone
is exposed to natural background radiation daily from sources
such as radon, food, water and the sun's rays. The average exposure
in the U.S. each year is estimated to be 360 mrem. To compare
the amount of radiation exposure in this research study, the
amount of radiation you will receive in one PET scan is about
in the same range as what you would receive in one year from
natural background sources. While there are no known risks associated
with receiving this level of radiation, radiation exposure adds
up throughout a person's lifetime. It is not possible to tell
whether the small additional radiation received by participating
in this study will increase your long-term risk for diseases
such as cancer.
MRI and fMRI Scan: Except for pacemakers and some types of metallic
implants, we know of no health hazard from the MRI scan or fMRI
scan. A MRI or fMRI should not be done during pregnancy because
of possible risk to the fetus.
In your MRI session, you will also undergo an fMRI. After the
MRI scan is complete, you will stay on the same table inside
the camera for an fMRI scan. You will be asked to wear soft goggles
so you can see a computer screen. Although you will be inside
the camera from your head to your knees, the goggles make it
seem like there is plenty of space around you. You will also
wear headphones and a microphone so you can hear us and speak
to us. We will put a small two-button keyboard under your hand.
We will show you pictures and ask you to press a button based
on what you see. This activity will take about thirty minutes.
5. What kind of treatment is provided?
Patients can be treated on either an in-patient or out-patient
basis. Treatment will consist of medication and cognitive behavior
therapy for up to six months. If you still need treatment after
this period has passed, you will be given referrals for continuing
treatment elsewhere.
None of the medications are experimental.
6. Can I be in multiple studies?
Yes. If you participate in this study you may also be eligible
to participate in one of our treatment studies.
7. Is psychotherapy involved in treatment?
Yes.
8. How often will I have to come in for treatment?
For at least the first eight weeks of treatment, you will meet
weekly with a psychiatrist. Visits may be spaced out after
that time depending on your symptoms.
9. What is the inpatient setting like?
The inpatient unit offers both group and individual therapy.
Patients have movies, magazines and a game room available for
their use. There are visiting hours daily
10. Will I be able to remain on my current medications?
No.
11. Can I participate if I’m doing
well on my current medications?
No.
12. Can I be in multiple studies?
Yes.
13. What if I cannot tolerate a medication washout?
Only patients who are expected to tolerate the washout will be
accepted into this study. If you do not think that you can
be off of medication for three weeks, you should not consider
participation
14. Can I continue seeing my current psychiatrist
if I participate?
No.
15. Will my records be confidential?
Yes, all records are confidential.
16. Will the results of my PET scan help
with my treatment?
PET scans results are performed for research purposes only. The
results will not provide helpful information about your illness
or guide your treatment.
17. What kind of training does the clinical staff
have?
All psychologists conducting interviews have a master’s
degree, at minimum, and most have Ph.D’s. All psychiatrists
administering medication are licensed M.D.’s.
18. What if I sign up for the study, but decide
later that I don’t want to participate?
Participation in this study is voluntary and you may choose to
discontinue your participation at any point.
Basic Information:
Principal Investigator:
Gregory Sullivan MD.
Title: Assistant Professor of Clinical Psychiatry
Division: Neuroscience
Address:
New
York State Psychiatric Institute (NYSPI), Unit 41
1051 Riverside Drive, Room 3619
New York, NY 10032
Phone:
For appointments, call Brendan Carroll, BA (212) 543-5902.
between 9am and 5pm.
|