Treatment-Resistant Depression
Conditions
Keywords
magnetic resonance imaging, magnetic resonance spectroscopy, depression, escitalopram, selective serotonin reuptake inhibitor, treatment-resistant depression, ziprasidone
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.
Interventions
None listed
Sponsors
Pfizer
Massachusetts General Hospital
Mclean Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glutamate level in antidepressant non-responders | 8 weeks after starting combination therapy phase | Glutamate levels are measured by magnetic resonance spectroscopy 8 weeks after starting treatment with ziprasidone or placebo in addition to escitalopram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Glutamine levels are measured by magnetic resonance spectroscopy 6 weeks after starting treatment with ziprasidone or placebo together with escitalopram. |
| Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment. | 8 weeks or 16 weeks | — |
| Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment | 8 weeks after starting combination therapy phase | Functional connectivity will be measured by performing fMRI in the resting state. |
| 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 | — |
| GABA level in antidepressant non-responders | 8 weeks | GABA levels are measured by magnetic resonance spectroscopy 6 weeks after starting treatment with ziprasidone or placebo together with escitalopram. |
Countries
United States
Outcome results
None listed