Status:
COMPLETED
Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
FEMALE
24-75 years
Phase:
PHASE4
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 ...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01919216
Start Date
January 1 2010
End Date
June 1 2016
Last Update
March 9 2020
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032