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 Overview

• Status: Completed
• Conditions: Mood Disorder
• Intervention / Treatment: Drug: Wellbutrin XL

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, L7L 4X3
      • Providence Care Mental Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Wellbutrin SR switched to Wellbutrin XL	Drug: Wellbutrin XL; Wellbutrin XL 300mg daily; Other Names: Bupropion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
This study is looking at the effect of Wellbutrin SR versus Wellbutrin XL on sleep quality	pre, 3-5days, 3-4weeks after wellbutrinXL

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: Roumen V. Milev, MD, Queen's University

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: February 4, 2008
• First Submitted That Met QC Criteria: February 14, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Wellbutrin SR
• Additional Relevant MeSH Terms: Mental Disorders; Depressive Disorder; Mood Disorders; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: PSIY-219-05