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 Overview:
This
study provides 2½ years of outpatient pharmacological
treatment and 2 months of family therapy, at no cost, to depressed
bipolar patients with a history of suicide attempt. There is
no placebo group, and the medications used are FDA-approved
mood stabilizers and antidepressants.
Eligibility:
- Ages
18 to 50
- Meet
criteria for some type of Bipolar Disorder
- Is
currently in a major depressive episode or a mixed episode
- Women
cannot be pregnant or lactating during the entire duration
of the study
- Has
made one or more suicide attempt(s)
Benefits
to participant:
- Free thorough
clinical evaluation by doctoral-level psychologist and/or
psychiatrist
- No-cost outpatient
pharmacological treatment for 2½ years and no-cost outpatient
family therapy for 2 months
For
more information about participating,
or if you have questions about the study, please contact:
Maria
Oquendo, MD or Lucia Sanchez-Diaz, BA
Phone:
212-543-6216
Email: lsanchez@neuron.cpmc.columbia.edu
Study
FAQs (Frequently Asked Questions):
1. What do I need to do in order to participate?
Complete an initial phone screen and then an in-person screen
to verify your eligibility for the study.
2. Is there compensation provided for the screening process?
No, you will not be compensated for the phone screen or the in-person
screen.
3. Is there compensation for participation in these studies?
How long would I have to wait to recieve compensation?
For the Bipolar (Lithium vs. Depakote) study, there is no compensation
given. The treatment offered at no cost is the compensation.
4. What risks are involved?
Lithium:
The possible side effects of lithium include diarrhea, vomiting,
shakiness, drowsiness, slowed thinking, weakening of muscles,
difficulty concentrating, acne, weight gain, change in thyroid
function (a hormone that regulates metabolic and other functions)
and increased urination (more frequent and more volume).
Depakote (Valproate):
The possible side effects of valproate include nausea,
diarrhea, vomiting, drowsiness, slowed thinking, weight gain, menstrual abnormalities,
headaches and rarely liver function abnormalities.
5. What kind of treatment is provided? Is treatment experimental?
Free outpatient medication management visits at the Neuroscience
Clinic for a period of 24 months. You will be randomly assigned
to lithium or valproate. Medications used in this study have
all been approved by the FDA (Food and Drug Administration).
We will not use experimental medications.
6. Is psychotherapy involved in treatment?
Psychotherapy is not provided, but you may see a therapist outside
of our study if you like.
7. How often will I have to come in for treatment?
For the Bipolar study (Lithium vs. Depakote), you will be asked
to come in for weekly meetings during the first 2 months of
the study. Afterwards, the visits are not as often, and you
will most likely keep monthly appointments, unless the MD sees
that you need to be seen more frequently.
8. Will I be able to remain on my current medications?
All cases are assessed one by one. In most cases, you will be
tapered off your current medications.
9. Can I
participate if I’m doing well on my current medications?
No.
10. Can I be in multiple studies?
Yes.
11. Can I continue seeing my current psychiatrist if I participate?
No. The psychiatrist that’s assigned
to you by will be your new psychiatrist. He will monitor your
medications and you should contact him if you feel any side effects
from the medications.
12.
What if I sign up for the study, but decide later that I
don’t want to participate?
You can stop participating in the study at anytime.
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