Neurobiological Bases of Placebo Response in Major Depressive Disorder

NCT01787240 | Terminated Phase 4 Results DMC

• 1 other identifier: 2012P001241
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Feasibility

  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).

  This would occur at the first study visit (screening).

Secondary Outcomes (2)

• Effects of Acute Tryptophan Depletion on Mood

  Baseline, Visit 10 (after 9 weeks in study)

• Effects of Acute Tryptophan Depletion on Mood

  Baseline, Visit 5 (4 weeks into study)

Other Outcomes (1)

• Effects of Acute Tryptophan Depletion on Serotonin Binding

  Visit 5 (after 4 weeks in study) or Visit 10 (after 9 weeks in study)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Drug: Placebo

Escitalopram 10mg

EXPERIMENTAL

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Drug: Escitalopram 10mg

Interventions

Escitalopram 10mg DRUG

Also known as: Lexapro

Escitalopram 10mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Depression Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Cristina Cusin
• Organization: MGH

ccusin@partners.org

617 726 6421

Study Officials

• Cristina Cusin, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor HMS

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: February 8, 2013
• Study Start: November 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 16, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)