Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder ?
Information source: Queen's University
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mood Disorder
Intervention: Wellbutrin SR (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Queen's University Official(s) and/or principal investigator(s):
Roumen V. Milev, MD, Principal Investigator, Affiliation: Queen's University
Overall contact:
Roumen Milev, MD, Phone: 613-548-5567, Ext: 5857
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. Thexl 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.
Clinical Details
Official title: Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder ?
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: this study is looking at the effect of Wellbutrin Sr versus Wellbutrin XL on sleep quality
Detailed description:
As the Wellbutrin SR formulation cannot be given more than 150 mg as a single dose, and
higher doses are commonly required for the treatment of depression, they have to be given at
least 8 hours apart in order to avoid peak plasma concentrations and to reduce 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Signed Patient Informed Consent
2. Patients with Major depressive Disorders (DSM-IV-TR - criteria used)
3. Out-patients
4. Males or females over 18 years of age
5. Patients currently using Wellbutrin SR
Exclusion Criteria:
1. Bipolar Disorder patients
2. Actively suicidal patients
3. Schizophrenia, Schizoaffective or other Psychotic Disorder
4. Pregnant women, as by pregnancy test at the beginning of the study.
5. Women in childbearing age, refusing to use appropriate contraception, or breastfeeding
mothers.
6. Patients with known hypersensitivity to bupropion.
7. Patients with severe or unstable medical conditions, which in the opinion of the
investigator would interfere with their progress or safety.
8. ECT or TMS treatments within the last three months
9. Patients who did not respond to previous treatment with bupropion.
10. Patients with history of seizure disorder.
11. Patients with history of eating disorders (e. g. bulimia, anorexia nervosa)
12. Patients using sleep aiding medication (Benzodiazepines, barbiturates
Locations and Contacts
Roumen Milev, MD, Phone: 613-548-5567, Ext: 5857
Providence Continuing Care Centre - Mental Health Services, Kingston, Ontario K7L 4X3, Canada; Recruiting
Roumen V. Milev, MD, Phone: 613-548-5567, Ext: 5857, Email: milevr@pccchealth.org
Roumen V. Milev, MD, Principal Investigator
Additional Information
Starting date: January 2007
Ending date: April 2008
Last updated: February 14, 2008
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