Official Title: “Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder?”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: November 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Wellbutrin XL
  • Wellbutrin XL 300mg daily

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Wellbutrin SR switched to Wellbutrin XL

Primary Measures

• 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
    Safety Issue?: No

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Queen's University

Overall Clinical Trial Officials and Contacts

Roumen V. Milev, MD Principal Investigator Queen's University  

Overall Contact: Roumen Milev, MD (613) 548-5567 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00616915

Study ID Number: PSIY-219-05

ClinicalTrials.gov Identifier: NCT00616915

Health Authority: Canada: Health Canada