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Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00456014
First received: April 2, 2007
Last updated: May 10, 2013
Last verified: May 2013

April 2, 2007
May 10, 2013
September 2006
May 2012   (final data collection date for primary outcome measure)
Remission of depressive symptoms [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Remission of depressive symptoms
Complete list of historical versions of study NCT00456014 on ClinicalTrials.gov Archive Site
Improvement in scores on the Hamilton Depression Rating Scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Improvement in scores on the Hamilton Depression Rating Scale
Not Provided
Not Provided
 
Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment
Biological Predictors of Response to Antidepressants

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • 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.
    Other Name: Lexapro
  • Drug: 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
  • Experimental: 1 - SSRI
    Participants will take escitalopram.
    Intervention: Drug: Escitalopram
  • Active Comparator: 2 - TCA
    Participants will take desipramine.
    Intervention: Drug: Desipramine
Miller JM, Hesselgrave N, Ogden RT, Zanderigo F, Oquendo MA, Mann JJ, Parsey RV. Brain serotonin 1A receptor binding as a predictor of treatment outcome in major depressive disorder. Biol Psychiatry. 2013 Nov 15;74(10):760-7. doi: 10.1016/j.biopsych.2013.03.021. Epub 2013 May 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of current major depressive disorder
  • Currently depressed
  • Subjects must be generally healthy with no significant medical problems, anemia/blood loss, or cardiac abnormalities
  • Likely to tolerate medication washout
  • Capacity to provide informed consent
  • Off of anti-coagulant/anti-platelet treatment for 10 days
  • Willing to travel to Brookhaven for PET scanning

Exclusion Criteria:

  • Current abuse of or dependence on alcohol or another substance (>6 months remission okay)
  • History of other major psychiatric disorders such as bipolar, schizophrenia, schizoaffective; anorexia or bulimia in past year
  • First degree family history of schizophrenia if subject is under 33
  • Unable/unwilling to discontinue all psychotropic medication that affects the serotonin system
  • Pregnant, breastfeeding, or planning to become pregnant during the study
  • A medical contraindication to antidepressants
  • Dementia
  • Prior head trauma with evidence of cognitive impairment
  • Well-documented failure of two or more SSRI AND tricyclic antidepressant (TCA) trials of adequate dose and duration
  • Metal implants, pacemaker, metal protheses or orthodontic appliance, the presence of shrapnel
  • Current past, present, or anticipated exposure to radiation
  • Actively suicidal
  • Lifetime history of glaucoma
  • Lack of response to >2 trials of antidepressant monotherapy of adequate dose and duration
  • Claustrophobia
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00456014
#6351R (formerly 5206), R01MH074813, DATR A3-NSS
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Ramin V. Parsey, MD, PhD Columbia University
Principal Investigator: Jeffrey M Miller, MD New York State Psychiatric Institute
New York State Psychiatric Institute
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP