Overview:
This study uses brain-imaging technology (PET scans) to visualize and research changes in brain chemistry that may cause an episode of depression and/or be associated with suicidal behavior.  In exchange for study participation, patients receive no-cost outpatient treatment for six months, or inpatient treatment, depending on their clinical needs.

Eligibility:

• Ages 18 to 65 years old
• Meets criteria for Major Depressive Disorder
• Currenlty depressed

Benefits to participant:

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

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

Brendan Carroll (Study Coordinator)
Phone: 212-543-5902
Email: depression-study@columbia.edu
Clinic hours: Monday to Friday, 9am-5pm

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 be compensated for time and travel expenses.  You will receive up to $150 for undergoing all of the scans and interviews.  As an inpatient, your compensation is up to 2 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: You will only be accepted into this study if you are not doing well on your current medication and you are expected to tolerate the medication washout. If you do not think that you can be off of medication for three weeks, you should not consider participation and we can refer you for further treatment. Participants will need to be off medication for at least three weeks prior to the procedure, or six weeks if they have been taking Prozac (fluoxetine). This carries the risk of worsening symptoms. If at any time during the study 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 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: The MRI scanner uses a large magnet to take pictures of the brain. Some people have reported sensations during the MRI scan, such as "tingling" or "twitching" (or, very rarely, a painful sensation), which are caused by changes in the magnetic field that can stimulate nerves in your body.  If you experience sensations and feel that these are uncomfortable, you can tell the MR technologist, and he or she will stop the scan immediately.  Occasionally, some people experience nervousness or claustrophobic feelings due to the scanner's small space.  If you encounter any discomfort, you can tell the MR technologist, and he or she will stop the scan immediately.  Despite these experiences, in our experience, no one has had sensations from the scanning that did not stop as soon as the scanning stopped.   Except for pacemakers, some types of metallic implants, and medicinal patches, we know of no health hazard from the MRI scan. There is a risk of burns from medicinal patches during the MRI; therefore, you will be asked to remove any patches prior to the scan session.  The MRI scan is not painful, but having to lie still in the enclosed space of the scanning table is uncomfortable for some people. An MRI should not be done during pregnancy because of possible risk to the fetus. The 3.0T MRI is still considered to be experimental, although the FDA has determined that it is a non-significant risk device, which poses no more than minimal risk to humans.

During the fMRI, we will show you pictures of relaxed and scared faces and ask you to press a button based on what you see.  It is possible that you may find the scared expressions to be mildly upsetting.  The risks for fMRI due to the magnet strength are exactly the same as the risks for the MRI portion of the study.

6. What kind of treatment is provided? Is treatment experimental?
Inpatients will offered up to 2 months of care on the General Research Unit at the New York Psychiatric Institute (5th floor). Treatment in this setting will be medication-based and determined by the study protocol. 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 treatment (doctor’s visits) in the Division of Neuroscience and one month of medication at no cost. Treatment in this setting will be medication-based and determined by the study protocol. 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 four weeks of treatment, your psychiatrsit herre will see you at least weekly.  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 in multiple studies?
Yes.

12. 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.

13. Can I continue seeing my current psychiatrist if I participate?
You can continue to be in psychotherapy with an outside psychiatrist or psychologist; however, your psychiatric medication needs will be taken care of by a study affiliated psychiatrist.

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

15. 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 board certified 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.