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Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder

This study is currently recruiting participants.
Verified July 2012 by Mclean Hospital
Sponsor:
Collaborators:
Pfizer
Massachusetts General Hospital
Information provided by (Responsible Party):
Tara Lauriat, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01598324
First received: May 9, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

This is an ancillary study to a clinical trial that is being conducted at Massachusetts General Hospital. Investigators at MGH are conducting a clinical trial to test the efficacy of ziprasidone together with escitalopram for treatment-resistant depression (NCT00633399). This observational study will involve magnetic resonance scans to examine brain chemistry (neurotransmitter levels), brain activity, and functional connections between brain regions before and after participating in the trial. The neurotransmitters of interest are glutamate, glutamine, and GABA. Comparisons will be made between individuals who receive ziprasidone and individuals who receive an inactive placebo. Differences between participants who respond to standard antidepressants and those who require additional medication will also be examined. All participants will have a baseline magnetic resonance scan before starting medication. The second scan will be after 8 weeks of escitalopram treatment for those who respond or following 8 weeks of escitalopram plus ziaprasidone or placebo (16 weeks after starting) for those who do not respond to escitalopram alone. Participants will complete standard rating scales for depression at each visit.


Condition
Treatment-Resistant Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Glutamate level in antidepressant non-responders [ Time Frame: 8 weeks after starting combination therapy phase ] [ Designated as safety issue: No ]
    Glutamate levels are measured by magnetic resonance spectroscopy 8 weeks after starting treatment with ziprasidone or placebo in addition to escitalopram.


Secondary Outcome Measures:
  • Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment. [ Time Frame: 8 weeks or 16 weeks ] [ Designated as safety issue: No ]
  • Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • GABA level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Glutamine level in antidepressant non-responders [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Glutamine levels are measured by magnetic resonance spectroscopy 6 weeks after starting treatment with ziprasidone or placebo together with escitalopram.

  • GABA level in antidepressant non-responders [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    GABA levels are measured by magnetic resonance spectroscopy 6 weeks after starting treatment with ziprasidone or placebo together with escitalopram.

  • Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment [ Time Frame: 8 weeks after starting combination therapy phase ] [ Designated as safety issue: No ]
    Functional connectivity will be measured by performing fMRI in the resting state.

  • Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment and treatment-responders receiving an antidepressant [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2012
Groups/Cohorts
escitalopram responders no augmentation
Participants who show a clinical response following 8 weeks on an SSRI will have a final magnetic resonance scan at the end of 8 weeks and will complete the study at that time.
Ziprasidone augmentation
Participants who do not respond to escitalopram and are randomized to ziprasidone augmentation will have a final magnetic resonance scan following 8 weeks on ziprasidone.
Placebo augmentation
Participants who do not respond to escitalopram and are randomized to placebo augmentation will have a final magnetic resonance scan following 8 weeks on placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants in a clinical trial for treatment-resistant depression who agree to have magnetic resonance scans

Criteria

Inclusion Criteria:

  • Aged 18-65
  • Meets DSM-IV criteria for major depressive disorder
  • Meets eligibility criteria for clinical trial of ziprasidone augmentation of escitalopram
  • Capable of providing informed consent

Exclusion Criteria:

  • Meets exclusion criteria for augmentation clinical trial protocol
  • Pregnancy or unwillingness to avoid pregnancy during trial
  • Current or past psychosis or bipolar disorder
  • Substance abuse or dependence in the past six months
  • Clinically significant suicidality
  • Unstable cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizures
  • Use of a concomitant medication that acts on glutamate or GABA neurotransmission
  • Contraindication to magnetic resonance imaging (metal implant or device, occupational metal exposure, significant claustrophobia)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598324

Contacts
Contact: Tara Lauriat, PhD 617-789-2404 tlauriat@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital - McLean Imaging Center Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Tara Lauriat, PhD         tlauriat@mclean.harvard.edu    
Sponsors and Collaborators
Mclean Hospital
Pfizer
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Tara Lauriat, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01598324     History of Changes
Other Study ID Numbers: WS2058787
Study First Received: May 9, 2012
Last Updated: July 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
magnetic resonance imaging
magnetic resonance spectroscopy
depression
escitalopram
 selective serotonin reuptake inhibitor
treatment-resistant depression
ziprasidone

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

ClinicalTrials.gov processed this record on May 23, 2013