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Trial record 9 of 34017 for:    Placebo AND placebo effect

Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms

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ClinicalTrials.gov Identifier: NCT01919216
Recruitment Status : Completed
First Posted : August 8, 2013
Results First Posted : January 5, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE August 5, 2013
First Posted Date  ICMJE August 8, 2013
Results First Submitted Date  ICMJE July 24, 2017
Results First Posted Date  ICMJE January 5, 2018
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
Hamilton Rating Scale for Depression [ Time Frame: 8 weeks ]
The patient is rated by a clinician among 24 dimensions with a score on a 3 or 5 point scale. A score of 0-9 is considered to be normal. Score between 10-18 is considered as mild depression, Scores between 19-26 indicate moderate, scores between 27-34 indicate severe, and score between 35-75 indicate very severe depression.
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
Hamilton Psychiatric Rating Scale for Depression [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT01919216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
  • Clinical Global Impression [ Time Frame: 8 weeks ]
  • Quick Inventory of Depression Scale [ Time Frame: 8 weeks ]
  • Hamilton Anxiety Rating Scale [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: August 6, 2013)
  • Picture Expectancy [ Time Frame: 2 weeks ]
    Assesses the participant's understanding of their percentage likelihood of receiving treatment with celexa, and their probability of improvement by the end of the study.
  • Quick Inventory of Depression Scale - Expectancy [ Time Frame: 8 weeks ]
    A Quick Inventory of Depression Scale that assesses how the participant expects to feel at the end of the study, or, at week 8, after 3 months of open treatment.
  • fMRI Scan [ Time Frame: 8 weeks ]
    Images are obtained using a GE Signa 3 Tesla whole body scanner, 3 fMRI tasks are done, FSPGR and DTI are collected.
 
Descriptive Information
Brief Title  ICMJE Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms
Official Title  ICMJE Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms
Brief Summary Studies of the neural mechanisms underlying placebo effects in antidepressant clinical trials largely have been limited to demonstrating objective differences in brain activity between responders and non-responders to placebo. This 8 week Placebo-controlled and Open groups study employs a novel antidepressant trial design with integrated functional magnetic resonance imaging (fMRI) to manipulate patient expectancy and examine its neural mediators.
Detailed Description

The placebo effect represents a potent treatment for Major Depressive Disorder (MDD)—placebo response in acute randomized controlled trials (RCTs) of antidepressant medications averages 30%, and meta-analyses have estimated the proportion of medication response attributable to placebo to be 50-75%. Patient expectancy is the mechanism of placebo effects in antidepressant RCTs and has been positively associated with medication response. Determining how expectancy alters the course of MDD could lead to methods of optimizing placebo effects and improving the treatment of MDD. In addition, investigating the neurobiology of placebo effects has the potential to elucidate the pathophysiology of MDD and the mechanisms of action of antidepressant treatments. Brain regions implicated in expectancy and placebo effects comprise prefrontal cortical (PFC) areas, amygdala, insular cortex, rostral anterior cingulate cortex (rACC), and dopaminergic reward pathways in the striatum. Pathological decreases in PFC and striatal function, increases in limbic activity, and disordered connectivity between these regions have all been observed in MDD, and the rostral and dorsal ACC have been repeatedly linked to antidepressant treatment response.

Therefore, studying placebo effects offers a window into the functioning of the neural circuits that are disturbed in MDD and improve with effective treatment. The goals of this study are to determine whether expectancy affects the outcome of antidepressant pharmacotherapy and to investigate the neural mechanisms of expectancy effects. These will be accomplished by conducting a clinical trial randomizing adult outpatients with MDD to 8 weeks of treatment in high vs. low expectancy conditions. The high expectancy condition will be open administration of citalopram, while the low expectancy condition will be placebo-controlled administration of citalopram. The neural mechanisms of expectancy will be determined using functional Magnetic Resonance Imaging (fMRI) paradigms to investigate treatment activation differences in brain regions associated with placebo effects and MDD.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: Citalopram
Other Name: Celexa
Study Arms  ICMJE
  • Active Comparator: Open Track
    Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.
    Intervention: Drug: Citalopram
  • Placebo Comparator: Placebo Track
    Blinded treatment with either citalopram 20mg or placebo, increased to citalopram 40mg or placebo at week 4 if depression has not remitted.
    Intervention: Drug: Citalopram
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2017)
65
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2013)
120
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women aged 24-75 years
  • Diagnosed with Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Major Depressive Disorder, nonpsychotic
  • 24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16
  • Willing to and capable of providing informed consent and complying with study procedures
  • Subjects are right-handed
  • Using appropriate contraceptive method if woman of child-bearing age

Exclusion Criteria:

  • Current comorbid Axis I DSM IV disorder other than Nicotine Dependence, Adjustment Disorder, Panic Disorder, Generalized Anxiety Disorder, or Social Phobia
  • Diagnosis of substance abuse or dependence (excluding Nicotine Dependence) within the past 12 months
  • History of psychosis or psychotic disorder, mania or bipolar disorder
  • Subject is considered to be at significant risk of suicide based on current mental status and recent history
  • History of allergic or adverse reaction to citalopram, or nonresponse to adequate trial of citalopram (at least 4 weeks at dose of 40mg) or escitalopram (at least 4 weeks at dose of 20mg)
  • Subject is considered based on history to be unlikely to respond to the single agent citalopram (i.e., subjects with treatment resistant depression)
  • Current treatment with psychotherapy
  • Clinical Global Impression (CGI)-Severity score of 7 at baseline Clinical Interview
  • Current or recent (within the past 4 weeks) treatment with any of the following: antidepressants, antipsychotics, mood stabilizers, isoniazid, glucocorticoids, opiates, centrally active antihypertensive drugs (e.g. clonidine, reserpine)
  • Subject has metal in body or prior history working with metal fragments (e.g., as a machinist), tattoos, or unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)
  • Acute, severe, or unstable medical illness
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 24 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01919216
Other Study ID Numbers  ICMJE 6038/6996R
K23MH085236 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Bret R Rutherford, MD New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date February 2018

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