Phase 4
N=40
Predictors of Antidepressant Response
Depression
Bottom Line
View on ClinicalTrials.gov: NCT02178696 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Changes in Mu-opioid Binding Potential During PET — 0.12 Binding potential ratio — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo, identified as placebo to participants (Other); Celexa or other antidepressant as clinically indicated (Drug); Placebo, identifed to participants as "Active medication" (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Mu-opioid Binding Potential During PET |
0.12 | <0.001 sig |
| PRIMARY Changes in BOLD Response During Reward fMRI Task (Monetary Incentive Delay, MID) |
0.04 | — |
| SECONDARY Changes in Dopamine (D 2/3) Binding Potential During PET. |
0.08 | — |
| SECONDARY Changes From Baseline in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) Score |
1.7; -0.5 | — |
| SECONDARY Changes From Baseline in PHQ-9 Depression Scores. |
1.6; 0.96 | — |
| SECONDARY Hamilton Depression Rating Scale Scores |
21; 17.2; 13.3; 11; 8.65; 5.3 | — |
| SECONDARY Montgomery-Asberg Depression Rating Scale |
27; 22; 15; 13; 11; 7.7 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02178696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.