Effects of Bupropion in Depression

NCT02104128 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-05-12

No results posted yet for this study

Summary

This study will investigate the role of dopaminergic neural systems in the symptoms and treatment of depression. 40 patients who meet DSM-IV criteria for a diagnosis of depression will be compared to a matched sample of healthy controls. The depressed group will receive open label treatment with Bupropion MR (150mg bd) for 6 weeks. The control group will receive no treatment. All participants will be assessed before treatment, after 2 weeks treatment and at 6 weeks treatment. The outcomes assessed will be 1) fMRI estimates of neural response to reward to emotionally valenced stimuli (1st and 2nd assessments), 2) computer based measures of emotional processing (all assessments) and 3) standardised questionnaire measures of depressive symptoms (all assessments). The primary study hypothesis is that altering central dopamine using Bupropion will lead to altered neural responses to rewarding stimuli in the depressed patients (i.e. comparing fMRI outcomes between assessment visits 1 and 2). A secondary hypothesis is that this neural change will predict subsequent symptom response to the bupropion (i.e. comparing symptom scores between assessment visits 1 and 3), Lastly, the study will test the hypothesis that baseline differences in reward circuitry will be particularly associated with symptoms of anhedonia (the inability to experience pleasure).

Conditions

Interventions

DRUG

Bupropion

Bupropion MR will be given open label to all participants in the depression group. Participants will receive 150mg od for one week. The dose will then be increased to 150mg bd for the following 5 weeks. Participants in the control group will recieve no drug. Note that the study is not assessing the safety or efficacy of buprion-- it is using bupropion to assess the neural effects of altering central dopaminergic function in depressed patients.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY
  • University of Oxford

    lead OTHER

Principal Investigators

  • Catherine Harmer, DPhil · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02104128 on ClinicalTrials.gov