PET Biomarkers in Treatment Resistant Depression

NCT01031810 | Terminated Phase 4 Results

• 2 other identifiers: 6025RC1MH088405-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Treatment Resistant depression; Major Depression; MDD; Depression

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale Scores 17 at Baseline

  HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor. Scale range (0-52): A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.

  Week 00 (baseline)

• Hamilton Depression Rating Scale Scores 17 at week12

  HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor. Scale range (0-52): A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.

  Week 12

Secondary Outcomes (4)

• Quick Inventory of Depression- Self Report 16

  Weeks 00

• Quick Inventory of Depression- Self Report 16

  Week 04

• Quick Inventory of Depression- Self Report 16

  Week 12

• Quick Inventory of Depression- Self Report 16

  Week 16

Study Arms (1)

tranylcypromine

OTHER

patients will receive treatment with tranylcypromine

Drug: tranylcypromine

Interventions

tranylcypromine DRUG

MAO-Inhibitor 60mg-120mg

Also known as: Parnate

tranylcypromine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of Major Depressive Disorder
• Subjects aged 18-65
• Depressed subjects must have Treatment-Resistant Depression (TRD) two previous adequate antidepressant treatment trial failures within the current depressive episode from different classes
• Minimum baseline Montgomery Asberg Depression Rating Scale (MADRS) score of 22
• Signs informed consent form
• Subjects must be willing to be have a PET scan
• Subjects must be antidepressant medication free for 3 weeks prior to PET scan

You may not qualify if:

• Significant past or present neurological disorder, including seizures, stroke, or head trauma
• History of bipolar disorder, psychosis, schizoaffective disorder, or schizophrenia
• 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.
• Personality disorder which might interfere with compliance or increase suicide risk
• 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
• Current thyroid dysfunction (past or currently treated dysfunction is acceptable)
• Clinically significant or unstable medical conditions or laboratory abnormalities, including hypertension (repeated BP \> 140 systolic, \> 90 diastolic)
• Intake of investigational (unapproved) drug in the past 3 months
• Electroconvulsive therapy (ECT) in three months prior to screening
• Use of Vagal Nerve Stimulation (VNS)
• Positive drug of abuse screen
• Anticoagulant treatment which cannot be discontinued for 10 days prior to PET scanning
• Pregnancy, currently lactating; planning to conceive during the course of study participation or abortion in the past two months.
• Dementia (clinical and neurocognitive criteria)
• Claustrophobia of a severity which would not permit the participant to undergo an MRI or a PET scan

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

• Depression Evaluation Service website
• New York State Psychiatric Institute official website
• Columbia University Psychiatry website

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Depression

Interventions

Tranylcypromine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Patrick J. McGrath
• Organization: New York State Psychiatric Institute

mcgrath@nyspi.columbia.edu

(646) 774-8076

Study Officials

• Patrick J McGrath, MD

  New York State Psychiatric Institute, Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2009
• First Posted: December 15, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 18, 2014
• Results First Posted: September 18, 2014

Record last verified: 2013-10

Locations

US (1)