Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder

NCT01598324

Last updated date
Study Location
McLean Hospital - McLean Imaging Center
Belmont, Massachusetts, 02478, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Treatment-Resistant Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Treatment-Resistant DepressionFunctional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder
NCT01598324
  1. Belmont, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder
Official Title Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants in a clinical trial for treatment-resistant depression who agree to have magnetic resonance scans
Condition Treatment-Resistant Depression
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: August 10, 2013)
1
Original Estimated Enrollment
 (submitted: May 12, 2012)
30
Study Completion Date Not Provided
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01598324
Other Study ID Numbers WS2058787
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tara Lauriat, Mclean Hospital
Study Sponsor Mclean Hospital
Collaborators
  • Pfizer
  • Massachusetts General Hospital
Investigators Not Provided
PRS Account Mclean Hospital
Verification Date August 2013