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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00456014
First received: April 2, 2007
Last updated: May 15, 2017
Last verified: May 2017
April 2, 2007
May 15, 2017
September 2006
May 2012   (Final data collection date for primary outcome measure)
Remission of Depressive Symptoms [ Time Frame: Measured at Week 8 ]
Remission in this study is defined as both a ≥50% decrease in the 24-item Hamilton Depression Rating Scale (HDRS) Score and a final 24-item HDRS score <10. Remission of depressive symptoms was calculated for the 28 completers of the SSRI phase.
Remission of Depressive Symptoms
Complete list of historical versions of study NCT00456014 on ClinicalTrials.gov Archive Site
  • Remission of Depressive Symptoms - Tricyclic Phase [ Time Frame: Measured over 8 weeks ]
    Participants who did not achieve remission during the SSRI phase advanced to the tricyclic phase of the study. Participants were treated with either desipramine or nortriptyline. Seven participants started the tricyclic phase. Four completed the tricyclic phase. The completers (n=4) were analyzed for remission status.
  • Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase [ Time Frame: Measured at Week 8 ]
    Mean % improvement from baseline to end of treatment trial using the 24-item Hamilton Depression Rating Scale. Percent improvement of depressive symptoms was calculated for the 28 completers of the SSRI phase. The higher the score on the 24-item HDRS, the greater the depression severity. Minimum score on the scale is 0, and maximum score is 74. Subscales are not used for this analysis.
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.

We will perform pretreatment PET scans to quantify serotonin transporter (5-HTT) and serotonin 1A (5-HT1A) receptor in patients with major depressive disorder (MDD). All patients will then receive a standardized treatment protocol with a selective serotonin reuptake inhibitor (SSRI), escitalopram. If the patient does not remit, he or she will receive a selective norepinephrine reuptake inhibitor (NRI), desipramine. We hypothesize those patients with high pre and postsynaptic 5-HT1A BP and low 5-HTT BP in specific brain regions will not remit to a SSRI and will remit to a selective NRI. Finally, we will generate a predictive model of remission based on brain imaging outcome measures. Our overall goal is to reduce the trial and error associated with antidepressant treatment by using data from pre-treatment quantification of 5-HT1A receptors and 5-HTT to guide antidepressant treatment selection.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
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
    Subsequent to escitalopram trial, non-remitters will be offered pharmacotherapy with 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 receive standardized pharmacotherapy with the SSRI escitalopram over 8 weeks. Non-remitters after 8 weeks will be offered standardized pharmacotherapy with desipramine
Interventions:
  • Drug: Escitalopram
  • 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
37
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00456014
#6351R (formerly 5206)
R01MH074813 ( US NIH Grant/Contract Award Number )
DATR A3-NSS
No
Not Provided
No
Not Provided
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 2017

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