Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00456014
First received: April 2, 2007
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

This study will use pre-treatment positron emission topography and functional magnetic resonance imaging scans of the brain to predict the most effective antidepressant treatment for people with major depressive disorder.


Condition Intervention
Depression
Drug: Escitalopram
Drug: Desipramine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biological Predictors of Response to Antidepressants

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Remission of depressive symptoms [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in scores on the Hamilton Depression Rating Scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: September 2006
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 - SSRI
Participants will take escitalopram.
Drug: Escitalopram
Escitalopram will be administered at a dose of 10 mg daily for 4 weeks. If participants have not achieved response (greater than 50 % improvement in Hamilton Depression Rating Scale) by 4 weeks, the dose will be increased to 20 mg. Remission status is determined after an 8-week trial.
Other Name: Lexapro
Active Comparator: 2 - TCA
Participants will take desipramine.
Drug: Desipramine
Desipramine will be initiated at a dose of 50 mg and titrated according to a treatment manual, with monitoring of therapeutic blood levels. Remission status is determined after an 8-week trial.
Other Name: Norpramin

Detailed Description:

Major depressive disorder (MDD) is characterized by a combination of symptoms that can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Studies have shown that as little as 50% to 60% of individuals with MDD may respond to the first antidepressant medication prescribed. Currently psychiatrists lack tools that allow them to select the treatment plan that is most likely to benefit a particular individual. Some of the chemical abnormalities in the brains of people with MDD are detectable on positron emission topography (PET) scans. There are distinct differences in the PET scans of people with MDD who respond to treatment with a selective serotonin reuptake inhibitor (SSRI), people with MDD who do not respond to SSRI treatment, and people who do not have MDD. This study will use pretreatment PET and functional magnetic resonance imaging (fMRI) scans of the brain to predict which antidepressants will be most effective in people with MDD. This may help to reduce the trial and error currently associated with antidepressant treatment.

Participants in this study will undergo one PET scan and one fMRI scan. Within 3 days of the scan, all participants will begin taking escitalopram, an SSRI, at a daily dose of 10 mg, or desipramine, a norepinephrine reuptake inhibitor (NRI), starting at 50mg and titrating to a therapeutic level. After 4 weeks, participants who have responded to treatment will continue for an additional 4 weeks on the current dose. Participants who are on escitalopram who do not respond to the medication at the end of 4 weeks will begin taking 20 mg of escitalopram per day. After 8 weeks on either medication, participants for whom medication does not succeed in relieving MDD symptoms will undergo a second antidepressant trial within the same class if this has not been done previously. Non-remitters to 2 within-class medication trials will be switched to the medication in the other group. Study visits will occur weekly for the first 4 weeks and then every other week for the remainder of the study. At visits, participants will meet with their psychiatrists to discuss how they have been feeling since the last visit, review medication side effects, and complete depression rating questionnaires. Outpatient participants will receive a total of 5 months of treatment for depression.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of current major depressive disorder
  • Currently depressed
  • Subjects must be generally healthy with no significant medical problems, anemia/blood loss, or cardiac abnormalities
  • Likely to tolerate medication washout
  • Capacity to provide informed consent
  • Off of anti-coagulant/anti-platelet treatment for 10 days
  • Willing to travel to Brookhaven for PET scanning

Exclusion Criteria:

  • Current abuse of or dependence on alcohol or another substance (>6 months remission okay)
  • History of other major psychiatric disorders such as bipolar, schizophrenia, schizoaffective; anorexia or bulimia in past year
  • First degree family history of schizophrenia if subject is under 33
  • Unable/unwilling to discontinue all psychotropic medication that affects the serotonin system
  • Pregnant, breastfeeding, or planning to become pregnant during the study
  • A medical contraindication to antidepressants
  • Dementia
  • Prior head trauma with evidence of cognitive impairment
  • Well-documented failure of two or more SSRI AND tricyclic antidepressant (TCA) trials of adequate dose and duration
  • Metal implants, pacemaker, metal protheses or orthodontic appliance, the presence of shrapnel
  • Current past, present, or anticipated exposure to radiation
  • Actively suicidal
  • Lifetime history of glaucoma
  • Lack of response to >2 trials of antidepressant monotherapy of adequate dose and duration
  • Claustrophobia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456014

Locations
United States, New York
Columbia University/New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Ramin V. Parsey, MD, PhD Columbia University
Principal Investigator: Jeffrey M Miller, MD New York State Psychiatric Institute
  More Information

No publications provided by New York State Psychiatric Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00456014     History of Changes
Other Study ID Numbers: #6351R (formerly 5206), R01MH074813, DATR A3-NSS
Study First Received: April 2, 2007
Last Updated: May 10, 2013
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Major Depression
Antidepressants

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Citalopram
Desipramine
Dexetimide
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Dyskinesia Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents

ClinicalTrials.gov processed this record on October 22, 2014