Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder

This study has been terminated.
(Clinical trial from which subjects were recruited closed to enrollment)
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: August 10, 2013
Last verified: August 2013

May 9, 2012
August 10, 2013
July 2012
April 2013   (final data collection date for primary outcome measure)
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.
Glutamate level in antidepressant non-responders [ Time Frame: 6 weeks after starting combination therapy phase ] [ Designated as safety issue: No ]
Glutamate levels are measured by magnetic resonance spectroscopy 6 weeks after starting treatment with ziprasidone, riluzole, or placebo.
Complete list of historical versions of study NCT01598324 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment. [ Time Frame: 6 weeks or 12 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: 6 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: 6 weeks ] [ Designated as safety issue: No ]
  • Glutamine level in antidepressant non-responders [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Glutamine levels are measured by magnetic resonance spectroscopy 6 weeks after starting treatment with ziprasidone, riluzole, or placebo.
  • GABA level in antidepressant non-responders [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    GABA levels are measured by magnetic resonance spectroscopy 6 weeks after starting treatment with ziprasidone, riluzole, or placebo.
  • Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment [ Time Frame: 6 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: 6 weeks ] [ Designated as safety issue: No ]
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Not Provided
 
Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder
Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

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

Treatment-Resistant Depression
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
Not Provided
April 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01598324
WS2058787
No
Tara Lauriat, Mclean Hospital
Mclean Hospital
  • Pfizer
  • Massachusetts General Hospital
Not Provided
Mclean Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP