Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Biological Predictors of Response to Antidepressants|
- Remission of depressive symptoms [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
- Improvement in scores on the Hamilton Depression Rating Scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: 1 - SSRI
Participants will take 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.
Other Name: Lexapro
Active Comparator: 2 - TCA
Participants will take desipramine.
Desipramine will be initiated at a dose of 50 mg and titrated according to a treatment manual, with monitoring of therapeutic blood levels. Remission status is determined after an 8-week trial.
Other Name: Norpramin
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, or desipramine, a norepinephrine reuptake inhibitor (NRI), starting at 50mg and titrating to a therapeutic level. After 4 weeks, participants who have responded to treatment will continue for an additional 4 weeks on the current dose. Participants who are on escitalopram 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 on either medication, participants for whom medication does not succeed in relieving MDD symptoms will undergo a second antidepressant trial within the same class if this has not been done previously. Non-remitters to 2 within-class medication trials will be switched to the medication in the other group. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456014
|United States, New York|
|Columbia University/New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Ramin V. Parsey, MD, PhD||Columbia University|
|Principal Investigator:||Jeffrey M Miller, MD||New York State Psychiatric Institute|