DepressionNCT02104128
Effects of Bupropion in Depression
A study testing Bupropion in people with Depression, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Depression
- Being tested
- Bupropion
- Keywords
- Anhedonia, Dopamine, Bupropion, fMRI, emotional processing, reward
- Medical subject headings
- Depression, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Zyban
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.
| Study group | Role | What they receive |
|---|---|---|
| Depressed patient given bupropion | Experimental | All depressed patients will be given open label bupropion Receives: Drug: Bupropion |
| Control pts given no intervention | No intervention | Control participants will be assessed at the same time points as the depressed group, but will be given no drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in haemodynamic (i.e. BOLD signal) response
fMRI data collected during a reward and emotional coding task
Measured: Baseline and 2 weeks
Secondary outcomes (2)
Change in questionnaire measures of subject mood and anhedonia
Standardised questionnaire measures of depressive symptoms and anhedonia.
Measured: baseline, 2 and 6 weeks
Change in accuracy and reaction time
Behavioral responses during computer based tasks measures cognition
Measured: baseline, 2 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Catherine Harmer, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104128
- Sponsor's protocol ID
- Bup_dep_1
- Other IDs
- 13/SC/0569, OxH 1005
- Status last verified
- May 2016
- First submitted
- 24 Mar 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bupropion in Depression
- ClinicalTrials.gov ID
- NCT02104128
- Acronym / sponsor ID
- Bup_dep_1
- Conditions
- Depression
- Keywords
- Anhedonia, Dopamine, Bupropion, fMRI, emotional processing, reward
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressed patient given bupropion | Experimental | Drug: BupropionAll depressed patients will be given open label bupropion |
| Control pts given no intervention | No intervention | –Control participants will be assessed at the same time points as the depressed group, but will be given no drug |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionAlso: ZybanBupropion 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. | Drug | Depressed patient given bupropion |
Primary outcome
Change in haemodynamic (i.e. BOLD signal) response
Time frame: Baseline and 2 weeks
fMRI data collected during a reward and emotional coding task
2 secondary outcomes
Change in questionnaire measures of subject mood and anhedonia
Time frame: baseline, 2 and 6 weeks
Change in accuracy and reaction time
Time frame: baseline, 2 and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Harmer, DPhil principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupropion in people with Depression, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in haemodynamic (i.e. BOLD signal) response (time frame: Baseline and 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.