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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Citalopram; Dexetimide

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