Phase 4 N=54 Randomized Quadruple-blind Treatment

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

Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01919216 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2018

Primary outcome: Primary: Hamilton Rating Scale for Depression — 10.79; 15.30; 12.75 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Citalopram (Drug)
Age: Adult, Older Adult · 24+ yrs
Sex: Female
Sponsor: New York State Psychiatric Institute
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Hamilton Rating Scale for Depression	10.79; 15.30; 12.75	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01919216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.