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

NCT01066897 | Terminated Phase 4 Results

• 2 other identifiers: SU-02042010-490217847
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Discontinued Study Due to Side-effects of the Medication

  throughout the 8 weeks

• % Change in Hamilton Depression Rating Scale From Baseline to week8

  Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores equals more depression. For the change score, where higher equals greater improvement in depressive symptoms. Healthy controls were not utilized in this analysis, as no week 8 ratings for health controls were obtained.

  Baseline and weeks 8

• Change in Mesolimbic Reward System Activity From Pre to Post Treatment (8 Weeks)

  Because of the limited number of depressed patients who completed the study (n=5) and noisy/unusable imaging data at various time points, this data was unable to be examined.

  baseline and Week 8

Secondary Outcomes (1)

• Mesolimibic Reward Activity Baseline Differences in Depression vs Healthy Controls

  Baseline

Study Arms (2)

Pramipexole

EXPERIMENTAL

Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (\> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.

Drug: Pramipexole

Healthy Controls

NO INTERVENTION

Non depressed, non-intervention comparison group

Interventions

Pramipexole DRUG

Patients will received increasing dose of pramipexole

Pramipexole

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).
• 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
• Significant abnormalities are observed in screening laboratory evaluation.

Sponsors & Collaborators

• Stanford University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The sample size is really too small for statistical analyses. Lack of funding prevented further recruitment.

Results Point of Contact

• Title: Dr. Jennifer Keller
• Organization: Stanford University

jkeller@stanford.edu

650-724-0070

Study Officials

• Jennifer Keller

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 16, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-04

Locations

US (1)