Mood DisorderPhase 1NCT00616915
Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder?
A Phase 1 study testing Wellbutrin XL in people with Mood Disorder, run by Queen's University at 1 site in Canada.
Trial summary
Wellbutrin (bupropion) is an effective antidepressant (Thase, M 2005). It exists in instant release (IR), sustained release (SR) and extended release (XL) forms. The IR formulation was never approved for use in Canada. The XL formulation allows for once daily dosing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disorder
- What is being tested?
- Wellbutrin XL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Jan 2010
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Patient Informed Consent;
- Patients with Major Depressive Disorders (DSM-IV-TR - criteria used);
- Out-patients;
- Males or females over 18 years of age;
- Patients currently using Wellbutrin SR.
Who cannot join
- Bipolar Disorder patients;
- Actively suicidal patients;
- Schizophrenia, Schizoaffective or other Psychotic Disorder;
- Pregnant women, as by pregnancy test at the beginning of the study;
- Women in childbearing age, refusing to use appropriate contraception, or breastfeeding mothers;
- Patients with known hypersensitivity to bupropion;
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- Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety;
- ECT or TMS treatments within the last three months;
- Patients who did not respond to previous treatment with bupropion;
- Patients with history of seizure disorder;
- Patients with history of eating disorders (e.g. bulimia, anorexia nervosa);
- Patients using sleep aiding medication (Benzodiazepines, barbiturates).
Trial locations and contacts
1 site in 1 country.
About this study
Wellbutrin (bupropion) is an effective antidepressant (Thase, M 2005). It exists in instant release (IR), sustained release (SR) and extended release (XL) forms. The IR formulation was never approved for use in Canada. The XL formulation allows for once daily dosing.
Wellbutrin is both a norepinephrine and dopamine reuptake inhibitor, and as such increases the synaptic concentration of both neurotransmitters. This adds to its positive effects on cognition, apathy, tiredness and executive functioning. The increased activation may be also responsible for some of its side effects such as initial insomnia and reduced sleep efficiency, especially when taken at night.
Read the detailed description
Wellbutrin SR formulation cannot be given as more than 150 mg as a single dose and higher doses are commonly required for the treatment of depression; they also have to be given at least 8 hours apart in order to avoid peak plasma concentrations and to reduce the risk of seizures (incidence of 0.1% at doses £ 300 mg). The twice a day dosing may result in complaints of insomnia and may necessitate discontinuing the medication or adding a sleep promoting agent. The benefit of once-daily dosing cannot be understated given treatment adherence is typically lower in depressed patients than their non-depressed counterparts; further, the 8 h dosing interval of bupropion SR is likely to have lower adherence compared with traditional bid dosing (i.e., morning and evening); thus, it is not difficult to imagine patients missing 30-50% of their second dose given the difficulty of recalling to take the second dose at work or school. The review of Fava et al. (2005) plots the relative PK profiles of XL and SR and notes the significantly lower bupropion concentration at bedtime, which is likely to reduce the occurrence of insomnia. Therefore, Wellbutrin XL may improve adherence by eliminating the second dose and Wellbutrin XL also avoids the high plasma drug concentrations at bedtime, as seen with bupropion SR, which are associated with insomnia. Further, the smoother pharmacokinetic profile of Wellbutrin XL may improve overall tolerability compared with Wellbutrin SR.
- Conditions
- Mood Disorder
- Being tested
- Wellbutrin XL
- Keywords
- Wellbutrin SR
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellbutrin XLDrug
Also called Bupropion
Wellbutrin XL 300mg daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Wellbutrin SR switched to Wellbutrin XL Receives: Drug: Wellbutrin XL |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study is looking at the effect of Wellbutrin SR versus Wellbutrin XL on sleep quality
Measured: pre, 3-5days, 3-4weeks after wellbutrinXL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisorderStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Roumen Milev, Queen's University
- Investigators
- Roumen V. Milev, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616915
- Sponsor's protocol ID
- PSIY-219-05
- Status last verified
- Dec 2015
- First submitted
- 4 Feb 2008
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder?
- ClinicalTrials.gov ID
- NCT00616915
- Acronym / sponsor ID
- PSIY-219-05
- Conditions
- Mood Disorder
- Keywords
- Wellbutrin SR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 15 Feb 2008 (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.
Wellbutrin (bupropion) is an effective antidepressant (Thase, M 2005). It exists in instant release (IR), sustained release (SR) and extended release (XL) forms. The IR formulation was never approved for use in Canada. The XL formulation allows for once daily dosing.
Wellbutrin is both a norepinephrine and dopamine reuptake inhibitor, and as such increases the synaptic concentration of both neurotransmitters. This adds to its positive effects on cognition, apathy, tiredness and executive functioning. The increased activation may be also responsible for some of its side effects such as initial insomnia and reduced sleep efficiency, especially when taken at night.
Detailed description
Wellbutrin SR formulation cannot be given as more than 150 mg as a single dose and higher doses are commonly required for the treatment of depression; they also have to be given at least 8 hours apart in order to avoid peak plasma concentrations and to reduce the risk of seizures (incidence of 0.1% at doses £ 300 mg). The twice a day dosing may result in complaints of insomnia and may necessitate discontinuing the medication or adding a sleep promoting agent. The benefit of once-daily dosing cannot be understated given treatment adherence is typically lower in depressed patients than their non-depressed counterparts; further, the 8 h dosing interval of bupropion SR is likely to have lower adherence compared with traditional bid dosing (i.e., morning and evening); thus, it is not difficult to imagine patients missing 30-50% of their second dose given the difficulty of recalling to take the second dose at work or school. The review of Fava et al. (2005) plots the relative PK profiles of XL and SR and notes the significantly lower bupropion concentration at bedtime, which is likely to reduce the occurrence of insomnia. Therefore, Wellbutrin XL may improve adherence by eliminating the second dose and Wellbutrin XL also avoids the high plasma drug concentrations at bedtime, as seen with bupropion SR, which are associated with insomnia. Further, the smoother pharmacokinetic profile of Wellbutrin XL may improve overall tolerability compared with Wellbutrin SR.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Wellbutrin XLWellbutrin SR switched to Wellbutrin XL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Patient Informed Consent;
- Patients with Major Depressive Disorders (DSM-IV-TR - criteria used);
- Out-patients;
- Males or females over 18 years of age;
- Patients currently using Wellbutrin SR.
Key exclusion criteria (12 listed)
- Bipolar Disorder patients;
- Actively suicidal patients;
- Schizophrenia, Schizoaffective or other Psychotic Disorder;
- Pregnant women, as by pregnancy test at the beginning of the study;
- Women in childbearing age, refusing to use appropriate contraception, or breastfeeding mothers;
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 |
|---|---|---|
| Wellbutrin XLAlso: BupropionWellbutrin XL 300mg daily | Drug | 1 |
Primary outcome
This study is looking at the effect of Wellbutrin SR versus Wellbutrin XL on sleep quality
Time frame: pre, 3-5days, 3-4weeks after wellbutrinXL
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 16 Dec 2015.
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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.
Roumen V. Milev, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Wellbutrin XL in people with Mood Disorder, run by Queen's University at 1 site in Canada.
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 12 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 16 Dec 2015. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
This study is looking at the effect of Wellbutrin SR versus Wellbutrin XL on sleep quality (time frame: pre, 3-5days, 3-4weeks after wellbutrinXL). 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 16 Dec 2015.