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

Completed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01919216

Run by

New York State Psychiatric Institute

People needed

65

Starts

2010-01-01

Expected to finish

2016-06-01

Last updated by the study team

2020-03-09

Who can join

Age: 24 and older, up to 75. Sex: female. Healthy volunteers: accepted.

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
• 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

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

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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