PET Biomarkers in Treatment Resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Intervention: tranylcypromine
Intervention description: MAO-Inhibitor 60mg-120mg
Intervention MeSH terms: Tranylcypromine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Treatment Resistant depression; Major Depression; MDD; Depression

Summary:

      The primary objectives of the study are to test whether brain Mono Amine Oxidase-A (MAO-A)
      levels are elevated in patients with treatment-resistant major depression, and to explore
      whether MAO-A brain levels predict treatment outcome with Mono Amine Oxidase Inhibitor (MAOI)
      medication in this population.
    

Eligibility criteria:

        INCLUSION:

          1. Primary diagnosis of Major Depressive Disorder

          2. Subjects aged 18-65

          3. Depressed subjects must have Treatment-Resistant Depression (TRD) two previous
             adequate antidepressant treatment trial failures within the current depressive episode
             from different classes

          4. Minimum baseline Montgomery Asberg Depression Rating Scale (MADRS) score of 22

          5. Signs informed consent form

          6. Subjects must be willing to be have a PET scan

          7. Subjects must be antidepressant medication free for 3 weeks prior to PET scan

        EXCLUSION

          1. Significant past or present neurological disorder, including seizures, stroke, or head
             trauma

          2. History of bipolar disorder, psychosis, schizoaffective disorder, or schizophrenia

          3. Moderate or high level of suicide risk, as determined by a score of 3 or 4 on item 3
             of the HAM-D scale. Also excluded will be those who present a significant suicide risk
             by history or current psychiatrist's assessment.

          4. Personality disorder which might interfere with compliance or increase suicide risk

          5. Alcohol or drug abuse or dependence in the past year; history of lifetime IV drug use
             or use of methylene diamine methamphetamine (MDMA or "ecstasy") more than twice

          6. Current thyroid dysfunction (past or currently treated dysfunction is acceptable)

          7. Clinically significant or unstable medical conditions or laboratory abnormalities,
             including hypertension (repeated BP > 140 systolic, > 90 diastolic)

          8. Intake of investigational (unapproved) drug in the past 3 months

          9. Electroconvulsive therapy (ECT) in three months prior to screening

         10. Use of Vagal Nerve Stimulation (VNS)

         11. Positive drug of abuse screen

         12. Anticoagulant treatment which cannot be discontinued for 10 days prior to PET scanning

         13. Pregnancy, currently lactating; planning to conceive during the course of study
             participation or abortion in the past two months.

         14. Dementia (clinical and neurocognitive criteria)

         15. Claustrophobia of a severity which would not permit the participant to undergo an MRI
             or a PET scan

         16. Recent (< 7 days) consumption of Ayahuasca Tea or other South American non-standard
             decoction.

         17. Presence of metallic devices, implants and other contraindications to scanning

         18. Current, past or anticipated exposure to radiation, that may include being badged for
             radiation exposure in the workplace or participation in nuclear medicine research
             protocols

         19. Smokers (use of tobacco products in the previous 3 months)

         20. Potential participants having taken an antidepressant medication in the last 3 weeks.
             Participants otherwise eligible may elect to discontinue medication which has not been
             significantly helpful according to their report, their current psychiatrist's report
             (if available), and the evaluating psychiatrist. No patient will be asked to
             discontinue an effective antidepressant medication to participate.

         21. History of previous MAO-I treatment