Imaging the Nucleus Accumbens in Major Depressed Patients 'Treated With Pramipexole

Stopped early · Phase 4

Conditions studied: Depression

In brief

We hope to learn how a brain circuit that is important to the understanding of depression, anhedonia and positive affect responds to a novel pharmaceutical treatment for depression and related symptoms. Adults who have a diagnosis of major depression and are not completely responsive to antidepressant medication will be sought out for participation; as will an equal number of adults not suffering from the disorder. Those suffering from depression will be given pramipexole, an investigational medication for eight weeks during which information will be collected about mood, cognition, and brain function. Adults not suffering from depression will also be evaluated with these measures.

Key facts

Study ID

NCT01066897

Run by

Stanford University

People needed

16

Starts

2010-02-01

Expected to finish

2013-02-01

Last updated by the study team

2017-05-16

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must meet DSM-IV criteria for Major Depressive Disorder
• HAM-D score >18 on a 21-item assessment at eligibility
• On at least an adequate dose of fluoxetine (40 mg/day), paroxetine (40 mg/day) paroxetine CR (50mg), sertraline (150 mg/day), citalopram (40 mg/day), escitalopram (20 mg/day), venlafaxine (150 mg/day), mirtazapine (30 mg/day), or duloxetine (60 mg/day) for at least 6 weeks (monotherapy).
• 20-55 years of age

You may not qualify if…

• Substance abuse in the past 6 months
• ECT in the past 6 months
• On a MAOI, tricyclic antidepressant, lithium, an antipsychotic, thyroid augmentation, 2 antidepressants simultaneously or lamotrigine
• History of any psychosis including psychotic depression
• History of Bipolar I, Bipolar II, or Bipolar NOS illness, or concurrent symptoms of mania or hypomania that do not meet the criteria for any bipolar disorder
• History of compulsive gambling
• Pregnant females or females of childbearing years not using adequate birth control in the opinion of the investigators
• Known sensitivity to Pramipexole
• Significant suicide risk in the opinion of the investigators
• Significant medical conditions that would preclude safe participation in the study in the opinion of the investigators
• Psychoactive drugs other than one of the antidepressants listed on Inclusion criteria #4. (A non-barbiturate sedative or hypnotic or benzodiazepine such as trazodone 50mg/day, zolpidem 10mg/day, lorazepam 3mg/day or clonazepam 2mg/day will be allowed if it has been in use for at least 1 month prior to the baseline visit.)
• Significant abnormalities are observed in screening laboratory evaluation.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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