Predictors of Antidepressant Response
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 12/7/2017 |
| Start Date: | January 2011 |
| End Date: | October 2015 |
Major depression is a highly prevalent, frequently debilitating illness that too often fails
to respond to currently available treatments such as antidepressant medication. Furthermore,
randomized controlled trials of antidepressants consistently demonstrate large placebo
effects. The investigators hypothesize that individual differences in the function of key
brain circuits underlie the observed variability in clinical responses to both placebo and
antidepressant medication. This study will test this hypothesis by recruiting
treatment-seeking volunteers with major depression, with or without comorbid nicotine
dependence. Volunteers will participate in positron emission tomography (PET) and functional
magnetic resonance imaging (fMRI) scans in the context of a treatment trial in which they
will receive both placebo and antidepressant medication. A major goal of the study is to
improve prediction of individual clinical responses in future treatment trials in which brain
imaging may be unavailable, and to study the mechanisms of antidepressant response in Major
Depression.
to respond to currently available treatments such as antidepressant medication. Furthermore,
randomized controlled trials of antidepressants consistently demonstrate large placebo
effects. The investigators hypothesize that individual differences in the function of key
brain circuits underlie the observed variability in clinical responses to both placebo and
antidepressant medication. This study will test this hypothesis by recruiting
treatment-seeking volunteers with major depression, with or without comorbid nicotine
dependence. Volunteers will participate in positron emission tomography (PET) and functional
magnetic resonance imaging (fMRI) scans in the context of a treatment trial in which they
will receive both placebo and antidepressant medication. A major goal of the study is to
improve prediction of individual clinical responses in future treatment trials in which brain
imaging may be unavailable, and to study the mechanisms of antidepressant response in Major
Depression.
We performed a single-blinded two-week cross-over randomized controlled trial of two
identical oral placebos (described as having either potentially "active" fast-acting
antidepressant-like effects or to be "inactive") followed by a 10-week open-label treatment
with a selective serotonin reuptake inhibitor (SSRI) or in some cases, another agent as
clinically indicated. The volunteers were studied with PET and the µ-opioid receptor
selective radiotracer [11C]carfentanil after each 1-week "inactive" and "active" oral placebo
treatment. In addition, 1 mL of isotonic saline was administered intravenously (i.v.) within
sight of the volunteer during PET scanning every 4 min over 20 min only after the 1-week
active placebo treatment, with instructions that the compound may be associated with the
activation of brain systems involved in mood improvement. This challenge stimulus was
utilized to test the individual capacity to acutely activate endogenous opioid
neurotransmission under expectations of antidepressant effect.
identical oral placebos (described as having either potentially "active" fast-acting
antidepressant-like effects or to be "inactive") followed by a 10-week open-label treatment
with a selective serotonin reuptake inhibitor (SSRI) or in some cases, another agent as
clinically indicated. The volunteers were studied with PET and the µ-opioid receptor
selective radiotracer [11C]carfentanil after each 1-week "inactive" and "active" oral placebo
treatment. In addition, 1 mL of isotonic saline was administered intravenously (i.v.) within
sight of the volunteer during PET scanning every 4 min over 20 min only after the 1-week
active placebo treatment, with instructions that the compound may be associated with the
activation of brain systems involved in mood improvement. This challenge stimulus was
utilized to test the individual capacity to acutely activate endogenous opioid
neurotransmission under expectations of antidepressant effect.
Inclusion Criteria: Inclusion criteria will include:
- Participants diagnosed with Major Depressive Disorder and will include Hamilton
Depressive Rating Scale (HDRS) scores >15
Exclusion Criteria:
- Comorbid conditions that are medical, neurological or psychiatric, pregnancy, use of
hormones (including birth control) or use of psychotropic agents
- We will only permit certain past anxiety disorder diagnoses, including generalized
anxiety, panic, agoraphobia, social phobia
- We also will exclude left-handed individuals and patients who have used any centrally
acting medications or recreational drugs with the past 2 months
- No history of an implant, pacemaker or pacemaker wires, open heart surgery, artificial
heart valve, brain aneurysm surgery, middle ear implant, hearing aid, braces or
extensive dental work, cataract surgery or lens implant, implanted mechanical or
electrical device, or artificial limb or joint
- No metallic object in their body (such as braces) or have a history of foreign
metallic object in the body such as bullets, BB's, pellets, shrapnel, or other metal
fragments
We found this trial at
1
site
Click here to add this to my saved trials
