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

NCT01919216 | Completed Phase 4 Results

• 2 other identifiers: 6038/6996RK23MH085236
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression

  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.

  8 weeks

Study Arms (2)

Open Track

ACTIVE COMPARATOR

Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.

Drug: Citalopram

Placebo Track

PLACEBO COMPARATOR

Blinded treatment with either citalopram 20mg or placebo, increased to citalopram 40mg or placebo at week 4 if depression has not remitted.

Drug: Citalopram

Interventions

Citalopram DRUG

Also known as: Celexa

Open Track; Placebo Track

Eligibility Criteria

• Age: 24 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 24-75 years
• Diagnosed with Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Major Depressive Disorder, nonpsychotic
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (2)

• Rutherford BR, Roose SP. A model of placebo response in antidepressant clinical trials. Am J Psychiatry. 2013 Jul;170(7):723-33. doi: 10.1176/appi.ajp.2012.12040474.

  PMID: 23318413 BACKGROUND

• Zilcha-Mano S, Wang Z, Peterson BS, Wall MM, Chen Y, Wager TD, Brown PJ, Roose SP, Rutherford BR. Neural mechanisms of expectancy-based placebo effects in antidepressant clinical trials. J Psychiatr Res. 2019 Sep;116:19-25. doi: 10.1016/j.jpsychires.2019.05.023. Epub 2019 May 26.

  PMID: 31176108 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Citalopram

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: Bret Rutherford
• Organization: New York State Psychiatric Institute

brr8@cumc.columbia.edu

6467748660

Study Officials

• Bret R Rutherford, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 8, 2013
• Study Start: January 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 9, 2020
• Results First Posted: January 5, 2018

Record last verified: 2020-02

Locations

US (1)