Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder

Mass General Brigham

Status: Terminated

Conditions: Treatment-Resistant Depression

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01598324

WS2058787

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

1 participants in 3 patient groups

escitalopram responders no augmentation

Description:

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

Description:

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

Description:

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.