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Trial record 85 of 531 for:    ESCITALOPRAM AND Disorders

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

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram 10mg Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Neurobiological Bases of Placebo Response in Major Depressive Disorder
Actual Study Start Date : November 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
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.
Drug: Escitalopram 10mg
Other Name: Lexapro




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


  2. 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.



Other Outcome Measures:
  1. 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




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787240


Locations
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United States, Massachusetts
Massachusetts General Hospital Depression Clinical and Research Program
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Cristina Cusin, M.D. Massachusetts General Hospital

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Responsible Party: Cristina Cusin, MD, Instructor HMS, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01787240     History of Changes
Other Study ID Numbers: 2012P001241
First Posted: February 8, 2013    Key Record Dates
Results First Posted: April 14, 2017
Last Update Posted: May 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Depression
Pathologic Processes
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents