Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder
NCT01598324
Last updated date
ABOUT THIS STUDY
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.
Study Location
McLean Hospital - McLean Imaging Center
Belmont, Massachusetts, 02478, United States
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
- 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 |
| ||
| 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 | 1 | ||
| Original Estimated Enrollment | 30 | ||
| Study Completion Date | Not Provided | ||
| Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender |
| ||
| 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 |
| ||
| Investigators | Not Provided | ||
| PRS Account | Mclean Hospital | ||
| Verification Date | August 2013 | ||