Advertisement

Topics

PET Biomarkers in Treatment Resistant Depression

2014-08-27 03:17:18 | BioPortfolio

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.

Description

While Major Depressive Disorder (MDD) is prevalent and disabling, compelling recent data from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study indicate that only about half of patients attain remission from MDD, even after multiple antidepressant medication trials. Further, no biomarker has been validated which can select an effective treatment for such patients, presenting critical unmet intellectual and clinical challenges. The recent landmark finding of an markedly elevated level of monoamine oxidase A (MAO-A) in the brains of depressed patients with MDD compared to controls, using positron emission tomography (PET) with a [11C] labeled monoamine oxidase inhibitor (MAOI), has provided an unparalleled opportunity to address these challenges. It has long been known that MAOIs are effective for some patients with treatment-resistant MDD, although their side effect profile makes them highly unacceptable both to patients and physicians, severely curtailing their utility.

This study seeks to: 1) replicate this study using PET scans in 20 subjects with MDD but extending it to patients with treatment-resistant depression (TRD). (Results from these participants with be compared to those from 10 non-depressed controls who have participated in IRB #5461 "Quantifying Cerebral Monoamine Oxidase-A Enzyme Activity by PET with [11C] methoxymethylpyridoindole: Test-retest and fMRI Correlation"); 2) explore the correlation of the brain MAO-A level biomarker to treatment outcome by treating the 20 PET-imaged TRD patients with an MAOI, hypothesizing that their MAOI response will be related to their level of MAO-A. Brain MAO-A is an ideal candidate biomarker for this study since it appears to be significantly abnormally elevated in MDD, yet it has a broad range of values even among depressed patients. Most importantly, the MAO-A biomarker is known to be the single pharmacologic target of the treatment, making it appear likely that outcome with MAOI treatment will be related to MAO-A.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Major Depressive Disorder

Intervention

tranylcypromine

Location

New York State Psychiatric Institute
New York
New York
United States
10032

Status

Recruiting

Source

New York State Psychiatric Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:18-0400

Clinical Trials [1614 Associated Clinical Trials listed on BioPortfolio]

Study Of 323U66 SR In Major Depressive Disorder

This study was designed to evaluate the efficacy and safety in major depressive disorder patients.

Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders

Escitalopram has been approved by FDA in the treatment of adolescents with major depressive disorder since March 2009. To date, there are only 3 clinical trials assessing the effect and va...

Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology

The purpose of this study is to evaluate feasibility and compliance with a novel method for assessing mood and cognition in participants with major depressive disorder (MDD).

An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder

A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)

Randomized, Placebo-Controlled Trial of an AMPAkine in Major Depressive Disorder

The purpose of this study is to test a candidate drug, Org 24448,in a phase II clinical trial in adult patients with moderately treatment-resistant unipolar major depressive disorder.

PubMed Articles [9898 Associated PubMed Articles listed on BioPortfolio]

Tranylcypromine Plus Amitriptyline for Electroconvulsive Therapy-Resistant Depression: A Long-Term Study.

Few therapeutic options are available for patients with electroconvulsive therapy-resistant major depressive disorder (ECT-r MDD), leaving a substantial proportion of this population beyond treatment ...

Neurophysiological Changes Associated with Antidepressant Response to Ketamine Not Observed in a Negative Trial of Scopolamine in Major Depressive Disorder.

This randomized, placebo-controlled, crossover trial examined the antidepressant efficacy of the muscarinic antagonist scopolamine in major depressive disorder subjects with more severe and refractory...

The Effect of Home Buddhist Mindfulness Meditation on Depressive Symptom in Major Depressive Patients.

Major depressive disorder (MDD) is the important cause of disability in the world. Major depressive patients that are not respond to the first and second drugs are about 67% and 33%, respectively. The...

Mood Disorders.

This article discusses the prevalence of the major mood disorders (major depressive disorder and bipolar disorder) in the community and within neurologic settings, articulates the steps taken to make ...

Persistent depressive disorder has long-term negative impacts on depression, anxiety, and somatic symptoms at 10-year follow-up among patients with major depressive disorder.

The study aimed to investigate the impacts of persistent depressive disorder (PDD) and pharmacotherapy on depression, anxiety, and somatic symptoms among patients with major depressive disorder (MDD) ...

Medical and Biotech [MESH] Definitions

A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.

A propylamine formed from the cyclization of the side chain of amphetamine. This monoamine oxidase inhibitor is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in panic and phobic disorders. (From AMA Drug Evaluations Annual, 1994, p311)

Marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation.

A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)

Inability to experience pleasure due to impairment or dysfunction of normal psychological and neurobiological mechanisms. It is a symptom of many PSYCHOTIC DISORDERS (e.g., DEPRESSIVE DISORDER, MAJOR; and SCHIZOPHRENIA).

More From BioPortfolio on "PET Biomarkers in Treatment Resistant Depression"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial