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Overview:
Our goal is to compare the effects of two different antidepressant
medications - bupropion (Wellbutrin) vs. an SSRI (Paxil) - in
depressed persons who have current suicidal ideation or a history
of a suicide attempt ever. We will study effects on suicidal
ideation and neuropsychological measures of impulsivity during
6-months of treatment for a Major Depressive Episode.
Patients receive 6 months free outpatient medication management (including
medication) in return for participation in the study. Both treatment groups
in this randomized double-blind clinical trial receive active medication; there
is no placebo. Patients may be in psychotherapy while in this study.
Inpatient admission, if necessary, is available (at start
or during study participation).
Eligibility:
- Ages
18 to 75 years old
- Current
suicidal ideation or history of a past suicide attempt ever
- Is
currently in a major depressive episode
- Must live within the New York City area, since patients are
required to come in regularly for clinical visits and research
interviews.
- Spanish speaking staff available
Ineligibility:
- Bipolar
Disorder
- Anorexia
or Bulimia
- Psychotic
symtoms
- Substance
Dependence ( substance abuse is not excluded)
- Unstable
medical problems
Benefits
to participant:
- Free clinical
evaluation by doctoral-level psychologist and/or psychiatrist
- No-cost outpatient
medication treatment for depression for 6 months. Inpatient
treatment is also available if necessary
For
more information about participating,
or if you have questions about the study, please contact:
Michael
Grunebaum, MD (Principal Investigator) or Lucia Sanchez-Diaz,
BA (Study Coordinator)
Phone: 212-543-6216
Email: lsanchez@neuron.cpmc.columbia.edu
Clinic hours: By appointment
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 Paxil vs. Wellbutrin study, there is no compensation
given. The treatment offered- at no cost- is the compensation.
4. What risks are involved?
Common side effects of Paxil and Wellbutrin are explained during
the informed consent process, prior to participation in this
research study.
5. What kind of treatment is provided?
Is treatment experimental?
Free outpatient medication management visits at the Neuroscience
Clinic for a period of 6 months. You will be randomly assigned
to Paxil CR or Wellbutrin XL. Medications used in this study
have all been approved by the FDA (Food and Drug Administration).
We will not use experimental medications or placebo (sugar pill).
Inpatient treatment is also available.
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?
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?
You may continue with a current therapist. The psychiatrist
assigned to you by the research study will prescribe and monitor
your medications and you should contact him if you feel any side
effects.
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 any time.
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