Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder

Treatment-Resistant Depression Clinical Trial

Official title:

Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01598324
• Other study ID #: WS2058787
• Status: Terminated
• Phase: N/A
• First received: May 9, 2012
• Last updated: August 10, 2013
• Start date: July 2012

Study information

• Verified date: August 2013
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Treatment-Resistant Depression

Locations

Country	Name	City	State
United States	McLean Hospital - McLean Imaging Center	Belmont	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Mclean Hospital	Massachusetts General Hospital, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment.		8 weeks or 16 weeks	No
Secondary	Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment		8 weeks	No
Secondary	GABA level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment		8 weeks	No
Secondary	Glutamine level in antidepressant non-responders	Glutamine levels are measured by magnetic resonance spectroscopy 6 weeks after starting treatment with ziprasidone or placebo together with escitalopram.	8 weeks	No
Secondary	GABA level in antidepressant non-responders	GABA levels are measured by magnetic resonance spectroscopy 6 weeks after starting treatment with ziprasidone or placebo together with escitalopram.	8 weeks	No
Secondary	Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment	Functional connectivity will be measured by performing fMRI in the resting state.	8 weeks after starting combination therapy phase	No
Secondary	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		8 weeks	No