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Neurobiological Bases of Placebo Response in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01787240
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : February 8, 2013
Results First Posted : April 14, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE January 16, 2013
First Posted Date  ICMJE February 8, 2013
Results First Submitted Date  ICMJE March 2, 2017
Results First Posted Date  ICMJE April 14, 2017
Last Update Posted Date May 16, 2017
Actual Study Start Date  ICMJE November 2012
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
Feasibility [ Time Frame: This would occur at the first study visit (screening). ]
We will measure the percentage of screened eligible patients who agree to be randomized. Participants were assessed for this Outcome Measure before randomization.This would occur at the first study visit (screening).
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
Feasibility [ Time Frame: This would occur at the first study visit (screening). ]
We will measure the percentage of screened eligible patients who agree to be randomized.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • Effects of Acute Tryptophan Depletion on Mood [ Time Frame: Baseline, Visit 10 (after 9 weeks in study) ]
    We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests. The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression. A negative change value refers to a decrease in HAM D score.
  • Effects of Acute Tryptophan Depletion on Mood [ Time Frame: Baseline, Visit 5 (4 weeks into study) ]
    We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests. The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression. A negative change value refers to a decrease in HAM D score.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
Effects of Acute Tryptophan Depletion on Mood [ Time Frame: Visit 5 (after 4 weeks in study) or Visit 10 (after 9 weeks in study) ]
We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests. The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.
Current Other Pre-specified Outcome Measures
 (submitted: April 18, 2017)
Effects of Acute Tryptophan Depletion on Serotonin Binding [ Time Frame: Visit 5 (after 4 weeks in study) or Visit 10 (after 9 weeks in study) ]
We will examine percentage changes in serotonin binding potential before and after acute tryptophan depletion within each region of interest. We will examine differences in serotonin binding potential between placebo responders and drug responders using a paired two-tailed t-test. Data were not collected
Original Other Pre-specified Outcome Measures
 (submitted: February 6, 2013)
Effects of Acute Tryptophan Depletion on Serotonin Binding [ Time Frame: Visit 5 (after 4 weeks in study) or Visit 10 (after 9 weeks in study) ]
We will examine percentage changes in serotonin binding potential before and after acute tryptophan depletion within each region of interest. We will examine differences in serotonin binding potential between placebo responders and drug responders using a paired two-tailed t-test.
 
Descriptive Information
Brief Title  ICMJE Neurobiological Bases of Placebo Response in Major Depressive Disorder
Official Title  ICMJE Neurobiological Bases of Placebo Response in Major Depressive Disorder
Brief Summary We are doing this research study to find out if people who get better while taking a specific kind of antidepressant medication (a selective serotonin reuptake inhibitor, or SSRI) and people who get better while taking placebo (an inactive substance) have similar chemicals in their brains. Some participants may complete a procedure called Acute Tryptophan Depletion (ATD), which is a way to study the role of serotonin in depression. Some participants may also undergo a magnetic resonance-positron emission tomography (MR-PET) scan.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Escitalopram 10mg
    Other Name: Lexapro
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
    Intervention: Drug: Placebo
  • Experimental: Escitalopram 10mg
    After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
    Intervention: Drug: Escitalopram 10mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 18, 2017)
20
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2013)
50
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meets diagnostic criteria for Major Depressive Disorder
  • Written informed consent
  • Men or women aged 18-60 years old
  • A score of 18 or greater on the HAMD-28
  • Patient must continue to meet criteria for current MDD at baseline. Patients must have Clinical Global Impression Improvement (CGI) scores ≥ 3 (i.e. minimally improved or less) from the screen to the baseline visit
  • Agreeing to, and eligible for all procedures (only patients 18-45 will be eligible for MR-PET study)

Exclusion Criteria:

  • Pregnant women or women of child bearing potential not using a medically accepted means of contraception
  • Patients who are a serious suicide or homicide risk
  • Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, uncontrolled seizure disorder
  • The following DSM-IV diagnoses: a) organic mental disorders b) substance use disorders, including alcohol, active within the last year; c) schizophrenia; d) delusional disorder; e) psychotic disorders not elsewhere classified; f) bipolar disorder; g) acute bereavement; h) borderline or antisocial personality disorder i) current primary diagnoses of panic disorder, social phobia, GAD, or OCD (disorders that present as chief complaint and/or have their onset preceding the onset of MDD), l) Patients with mood congruent or mood incongruent psychotic features
  • Currently taking any of the following exclusionary medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants, antidepressants, potential antidepressant augmenting agents (e.g., T3, SAMe, St. John's Wort, lithium, buspirone, Omega 3 fatty acids). If it is determined that it is safe to discontinue a medication, the patient will be required to wait a period equivalent to at least 5 half lives of the drug before the screening
  • Patients who have taken an investigational psychotropic drug within the last year
  • Patients who have not responded to one or more antidepressant trials of adequate doses (e.g., fluoxetine 40 mg/day or higher) and duration (e.g., for six weeks or more) over the past five years, as defined by the MGH-ATRQ
  • History of inadequate response or poor tolerability to citalopram or escitalopram
  • Any concomitant form of psychotherapy (depression-focused)
  • Receiving or have received during the index episode Vagal nerve stimulation, ECT or rTMS, or other somatic antidepressant treatments
  • Any reason not listed, determined by the site PI or study clinician, constituting good clinical practice and making participation in the study hazardous
  • Contraindications to fMRI scanning and MR-PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia)
  • MR-PET-specific exclusion criteria: Patients who are younger than 18 or older than 45 years of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01787240
Other Study ID Numbers  ICMJE 2012P001241
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cristina Cusin, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cristina Cusin, M.D. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2017

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