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Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder

NCT ID: NCT01598324

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Brief Summary

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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

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Conditions

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Treatment-Resistant Depression

Keywords

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magnetic resonance imaging magnetic resonance spectroscopy depression escitalopram selective serotonin reuptake inhibitor treatment-resistant depression ziprasidone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tara Lauriat

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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McLean Hospital - McLean Imaging Center

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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WS2058787

Identifier Type: -

Identifier Source: org_study_id