Clinical trial NCT01598324: Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder
Official title: Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Treatment-Resistant Depression
Keywords: magnetic resonance imaging
magnetic resonance spectroscopy
depression
escitalopram
selective serotonin reuptake inhibitor
treatment-resistant depression
ziprasidone
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Massachusetts General Hospital
First posted: 2012-05-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in a clinical trial for treatment-resistant depression who agree to have magnetic resonance scans

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.


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)

Primary outcomes:
measure: Glutamate level in antidepressant non-responders
timeFrame: 8 weeks after starting combination therapy phase
Secondary outcomes:
measure: Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment.
timeFrame: 8 weeks or 16 weeks
measure: Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment
timeFrame: 8 weeks
measure: GABA level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment
timeFrame: 8 weeks
measure: Glutamine level in antidepressant non-responders
timeFrame: 8 weeks
measure: GABA level in antidepressant non-responders
timeFrame: 8 weeks
measure: Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment
timeFrame: 8 weeks after starting combination therapy phase
measure: 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
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital - McLean Imaging Center
state: Massachusetts
Study officials:
References: