Major Depressive Disorder Clinical Trial
Official title:
Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms
Verified date | February 2020 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 24 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | National Institute of Mental Health (NIMH) |
United States,
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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