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Effects of Bupropion in Depression

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ClinicalTrials.gov Identifier: NCT02104128
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
University of Oxford

Brief 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).

Condition or disease Intervention/treatment Phase
Depression Drug: Bupropion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Bupropion in Depression
Study Start Date : January 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Depressed patient given bupropion
All depressed patients will be given open label bupropion
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.
Other Name: Zyban

No Intervention: Control pts given no intervention
Control participants will be assessed at the same time points as the depressed group, but will be given no drug



Primary Outcome Measures :
  1. Change in haemodynamic (i.e. BOLD signal) response [ Time Frame: Baseline and 2 weeks ]
    fMRI data collected during a reward and emotional coding task


Secondary Outcome Measures :
  1. Change in questionnaire measures of subject mood and anhedonia [ Time Frame: baseline, 2 and 6 weeks ]
    Standardised questionnaire measures of depressive symptoms and anhedonia.

  2. Change in accuracy and reaction time [ Time Frame: baseline, 2 and 6 weeks ]
    Behavioral responses during computer based tasks measures cognition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants must have signed an informed consent document indicating they understand the purpose of the study and the procedures required for the study and are willing to participate by complying with the study procedures and restrictions
  • Participants will be male or female and aged between 18 and 50
  • Participants will have a Body Mass Index (BMI) 18 to 36 kg/m2 (inclusive) at the Screening Visit.
  • The MDD participants must satisfy a diagnosis of MDD as determined by structured clinical interview for DSM-V (SCID) conducted by a psychiatrist. The MDD subtypes characterized under DSM-V also will be determined for use during post hoc tests aimed at characterizing further the heterogeneity extant within the MDD population.
  • Participants must be sufficiently fluent in English to complete the emotional and reward tasks.

Exclusion Criteria:

  • Current use of psychotropic medication or electroconvulsive therapy (within three weeks of the baseline assessments) or psychological treatment (within 3 months of the baseline assessments)
  • They are left handed (the site of brain activations vary depending on handedness)
  • They are not fluent in English
  • History of stimulant abuse (lifetime; e.g., amphetamine, cocaine), or of alcohol abuse within one year or of alcohol dependence within the lifetime.
  • History of, or current medical conditions which in the opinion of the investigator may interfere with the scientific assessments or safety of the participant, including brain injury, epilepsy/seizures, severe hepatic cirrhosis and CNS tumour.
  • Clinically significant abnormal values for liver function tests, clinical chemistry, urine drug screen, blood pressure measurement and ECG. It is expected that laboratory values will generally be within the normal range for the laboratory. NB clinical significance will be determined by a qualified study medic who will review the results and the participant.
  • Current pregnancy or breastfeeding
  • Smoker > 10 cigarettes per day or similar levels of tobacco consumption in other forms. History of smoking within 8 weeks of becoming abstinent.
  • Any contraindication to MRI scanning, for example any metal implants in the body that include ferromagnetic objects in their bodies (e.g., metal implants, vessel clips, shrapnel injuries) or with implanted devices which may be damaged by the magnet (e.g., heart pacemakers).
  • Participation in a psychological or medical study involving the use of medication within the last 3 months. Previous participation in any study involving the emotional test battery.
  • Has clinically significant risk of suicidal behaviour.
  • Medical conditions that may alter the hemodynamic parameters underlying the BOLD signal (e.g., inadequately treated hypertension, diabetes mellitus).

The following exclusion criteria apply specifically to the participants in the MDD group:

  • Any known allergy, hypersensitivity or intolerance to bupropion or its excipients.
  • Has any contraindication to the use of bupropion.
  • Any medical contraindication, for example conditions or treatments that may alter the absorption of bupropion such as surgical treatments involving the gut.
  • History of or current Axis 1 DSM-V psychiatric disorder (except depression or anxiety disorders such as specific phobia or social anxiety disorder for the MDD group and drug abuse subject to the criteria outlined below).The presence of co-morbid anxiety disorders will be recorded for potential use in post hoc exploratory analyses of the influence of such conditions on the outcome measures

The following criteria apply specifically to participants in the healthy control group:

• History of or current Axis 1 DSM-V psychiatric disorder


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104128


Locations
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United Kingdom
University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Sponsors and Collaborators
University of Oxford
Janssen Research & Development, LLC
Investigators
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Principal Investigator: Catherine Harmer, DPhil University of Oxford

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02104128     History of Changes
Other Study ID Numbers: Bup_dep_1
13/SC/0569 ( Other Identifier: NRES Ethics Committee )
OxH 1005 ( Other Identifier: Oxford Health R&D )
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by University of Oxford:
Anhedonia
Dopamine
Bupropion
fMRI
emotional processing
reward
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors