NCT01598324

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

9 months

First QC Date

May 9, 2012

Last Update Submit

August 10, 2013

Conditions

Treatment-Resistant Depression

Keywords

magnetic resonance imagingmagnetic resonance spectroscopydepressionescitalopramselective serotonin reuptake inhibitortreatment-resistant depressionziprasidone

Outcome Measures

Primary Outcomes (1)

  • Glutamate level in antidepressant non-responders

    Glutamate levels are measured by magnetic resonance spectroscopy 8 weeks after starting treatment with ziprasidone or placebo in addition to escitalopram.

    8 weeks after starting combination therapy phase

Secondary Outcomes (7)

  • Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment.

    8 weeks or 16 weeks

  • Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment

    8 weeks

  • GABA level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment

    8 weeks

  • Glutamine level in antidepressant non-responders

    8 weeks

  • GABA level in antidepressant non-responders

    8 weeks

  • +2 more secondary outcomes

Study Arms (3)

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 Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital - McLean Imaging Center

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 15, 2012

Study Start

July 1, 2012

Primary Completion

April 1, 2013

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations

US(1)