Overview:
This study uses brain imaging technology (PET scans) to visualize and research brain biochemistry, as well as a lumbar puncture procedure (spinal tap) to research biological elements identified with depression and suicidal behavior. In exchange for study participation, patients receive no-cost inpatient or outpatient treatment between two to six months, depending on their clinical needs.

Eligibility:

• Ages 18 to 65
• Meets criteria for Major Depressive Disorder or any type of Bipolar Disorder
• Currently depressed

Benefits to participant:

• Free, thorough clinical evaluation by doctoral-level psychologist and/or psychiatrist
• No-cost inpatient or outpatient treatment

For more information about participating,
or if you have questions about the study, please contact:

Sarah Feldman, BA
Phone: 212-543-5834
Email: sarahf@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 this study?
As an outpatient, you will receive $200 for the lumbar puncture; $150-$350 for the PET scans and an additional $150 for completing ratings with a neuropsychologist. As an inpatient, your compensation is two months of care on the inpatient unit.

4. How long would I have to wait to receive compensation?
Compensation is received 4-6 weeks after completing the study and is in the form of a check.

5. What risks are involved?
Clinical Assessment and Neuropsychological Interview:
Psychiatric interviews can sometimes be distressing, but some people find talking to a psychologist helpful. There are no known risks associated with a blood draw, other than slight discomfort and occasional bruising.

Medication Washout:
Participants will need to be off medication for up to three weeks prior to the procedure. This carries the risk of worsening symptoms. If you feel you cannot tolerate further delay in treatment, you will be withdrawn from the study and treated with medication.

Arterial Catheter:
Before the brain imaging scans, an arterial catheter (an I.V.) 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.

MRI and PET Scans:
During the PET scan, you will be exposed to low levels of radiation. Although health hazards from such low levels have never been show, radiation risk is cumulative over a lifetime, and additional exposure should be carefully considered.
Except for pacemakers and some types of metallic implants, we know of no health hazard from the MRI scan. A MRI should not be done during pregnancy because of possible risk to the fetus.

Lumbar Puncture:
Some participants experience headaches and backaches after the lumbar puncture. These symptoms are easily treated with bed rest and medications.

6. What kind of treatment is provided? Is treatment experimental?
Inpatients will offered up to two months of care on the General Research Unit at the New York Psychiatric Institute (5th floor). Treatment in this setting will be medication-based. If you still need treatment after this period has passed, you will be given referrals for continuing treatment elsewhere.

Outpatients will receive up to 6 months of care by both a psychiatrist and a psychologist who will carefully monitor progress. Treatment in this setting will be medication-based. 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.

7. Is psychotherapy involved in treatment?
No.

8. How often will I have to come in for treatment?
For the first month of treatment you will meet weekly with a psychiatrist. After that appointments occur at minimum monthly.

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. Will my activity level be limited after a lumbar puncture?
You will be asked to rest for about 2 hours after the procedure. You will be advised to avoid strenuous activity for the rest of the day.

14. What if I cannot tolerate a medication washout?
If you cannot tolerate a medication washout you will not be accepted into our study.

15. Can I continue seeing my current psychiatrist if I participate?
No.

16. Will my records be confidential?
Yes, all records are confidential.

17. Will the results of my PET scan or LP help with my treatment?
Imaging scans and LP results are performed for research purposes only. The results will not provide helpful information about your illness or guide your treatment.

18. 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 board certified M.D.’s.

19. 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.