Phase 4
Completed N=52
Imaging Dopamine Release in Depression
Source: ClinicalTrials.gov NCT02033369 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Change in Hamilton Rating Scale for Depression — 8.4 units on a scale
◆ Published Evidence
Established
97citations · ~16 / year
Baseline reward processing and ventrostriatal dopamine function are associated with pramipexole response in depression.
Summary
This study aims to determine whether ventral striatal dopamine release is a mechanism of reward motivation in major depression, whether dopamine release is low in depression, and whether DA release and reward motivation predict response to dopamine-targeted treatment with pramipexole.
Linked Publications (2)
-
Baseline reward processing and ventrostriatal dopamine function are associated with pramipexole response in depression.
-
Dopamine Release in Antidepressant-Naive Major Depressive Disorder: A Multimodal [<sup>11</sup>C]-(+)-PHNO Positron Emission Tomography and Functional Magnetic Resonance Imaging Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Rating Scale for Depression |
8.4 | — |
| SECONDARY Change in Snaith Hamilton Pleasure Scale |
26 | — |
| SECONDARY Change in Temporal Experience of Pleasure Scale - Anticipatory Subscale |
43.2 | — |
| SECONDARY Change in Mood and Anxiety Symptom Questionnaire, Short Form |
123.1 | — |
| SECONDARY Change in the Apathy Evaluation Rating Scale |
31.7 | — |
| SECONDARY Change in Clinical Global Improvement - Severity Scale |
2.59 | — |
| SECONDARY Change in Temporal Experiences of Pleasure Scale -- Consummatory Subscale |
35.6 | — |
Eligibility Criteria
Inclusion Criteria
- Weight between 44 kg and 115 kg
- Meets DSM-IV criteria for principal diagnosis of MDD, current major depressive episode, without psychotic features
- Score of >16 and 140 or diastolic blood pressure > 90 based on at least two readings at rest
- History of untoward reaction to amphetamine or other stimulant medication, or pramipexole
- Any psychotropic treatment in the past 3 weeks (or depot medication in the past 6 months), except for lorazepam,which may be administered as needed prior to imaging day
- Current, past or anticipated exposure to radiation in the workplace, or participation in nuclear medicine procedures, including research protocols (In case of previous exposure to activity due to research studies, subjects will be eligible if all conditions listed below are fulfilled: 1) The injected dose and dosimetry of the radiotracer are known; 2) Except for research studies, the subject has not been exposed to radiation (workplace and medical); 3) Adding prior exposure to the exposure due to the study will result in a yearly cumulative exposure lower than the FDA limit for research studies
- Family history of schizophrenia in parents, siblings, or children
- Ongoing cognitive-behavioral or interpersonal psychotherapy for depression (Supportive therapy is not an exclusion)
- Ongoing treatment with cimetidine
Data sourced from ClinicalTrials.gov (NCT02033369) and the linked publication. 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. Informational only — not medical advice.