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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00456014 |
Purpose
This study will use pre-treatment positron emission topography and functional magnetic resonance imaging scans of the brain to predict the most effective antidepressant treatment for people with major depressive disorder.
| Condition | Intervention |
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Depression |
Drug: Escitalopram Drug: Desipramine |
| MedlinePlus related topics: | Depression |
| ChemIDplus related topics: | Desipramine Desipramine hydrochloride Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Biological Predictors of Response to Antidepressants |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Participants will take escitalopram.
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Drug: Escitalopram
Escitalopram will be administered at a dose of 10 mg daily for 4 weeks. If participants have not achieved response (greater than 50 % improvement in Hamilton Depression Rating Scale) by 4 weeks, the dose will be increased to 20 mg. Remission status is determined after an 8-week trial.
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2: Active Comparator
Participants will take escitalopram plus desipramine.
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Drug: Escitalopram
Escitalopram will be administered at a dose of 10 mg daily for 4 weeks. If participants have not achieved response (greater than 50 % improvement in Hamilton Depression Rating Scale) by 4 weeks, the dose will be increased to 20 mg. Remission status is determined after an 8-week trial.
Drug: Desipramine
Participants who are unresponsive to the 8-week escitalopram trial will then undergo an 8-week trial at a therapeutic level of desipramine. Desipramine will be initiated at a dose of 50 mg and titrated according to a treatment manual, with monitoring of therapeutic blood levels.
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Major depressive disorder (MDD) is characterized by a combination of symptoms that can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Studies have shown that as little as 50% to 60% of individuals with MDD may respond to the first antidepressant medication prescribed. Currently psychiatrists lack tools that allow them to select the treatment plan that is most likely to benefit a particular individual. Some of the chemical abnormalities in the brains of people with MDD are detectable on positron emission topography (PET) scans. There are distinct differences in the PET scans of people with MDD who respond to treatment with a selective serotonin reuptake inhibitor (SSRI), people with MDD who do not respond to SSRI treatment, and people who do not have MDD. This study will use pretreatment PET and functional magnetic resonance imaging (fMRI) scans of the brain to predict which antidepressants will be most effective in people with MDD. This may help to reduce the trial and error currently associated with antidepressant treatment.
Participants in this study will undergo one PET scan and one fMRI scan. Within 3 days of the scan, all participants will begin taking escitalopram, an SSRI, at a daily dose of 10 mg. After 4 weeks, participants who have responded to treatment will continue for an additional 4 weeks at a 10-mg daily dose. Participants who do not respond to the medication at the end of 4 weeks will begin taking 20 mg of escitalopram per day. After 8 weeks, participants for whom escitalopram does not succeed in relieving MDD symptoms will take desipramine, a norepinephrine reuptake inhibitor (NRI), for an additional 8 weeks. If desipramine is ineffective, participants may receive any treatment agreed upon by their treating physicians. Study visits will occur weekly for the first 4 weeks and then every other week for the remainder of the study. At visits, participants will meet with their psychiatrists to discuss how they have been feeling since the last visit, review medication side effects, and complete depression rating questionnaires. Outpatient participants will receive a total of 5 months of treatment for depression, and inpatient participants will receive treatment until they have achieved remission.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Katrina Bruckschwaiger, BS | 212-543-0483 | depression-study@columbia.edu |
| Contact: Orlando Diaz, MA | 212-543-6503 | od2003@columbia.edu |
| United States, New York | |||||
| Columbia University | Recruiting | ||||
| New York, New York, United States, 10032 | |||||
| Contact: Katrina Bruckschwaiger, BS 212-543-0483 depression-study@columbia.edu | |||||
| Principal Investigator: Ramin V. Parsey, MD, PhD | |||||
| Principal Investigator: | Ramin V. Parsey, MD, PhD | Columbia University |
More Information
Click here for Columbia University and NYSPI's Department of Neuroscience Web site
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| Responsible Party: | NYSPI ( Ramin V. Parsey, PhD ) |
| Study ID Numbers: | R01 MH74813, DATR A3-NSS |
| First Received: | April 2, 2007 |
| Last Updated: | April 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00456014 |
| Health Authority: | United States: Federal Government |
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