What You Need to Know
FAQ
Research Study:
Antidepressant Medication Treatment (Paxil CR or Wellbutrin XL) for Major Depressive Disorder.
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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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