Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder?

NCT ID: NCT00616915

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-01-31

Brief 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.

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.

Conditions

Mood Disorder

Keywords

Wellbutrin SR

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Wellbutrin SR switched to Wellbutrin XL

Group Type: OTHER

Wellbutrin XL

Intervention Type: DRUG

Wellbutrin XL 300mg daily

Interventions

Wellbutrin XL

Wellbutrin XL 300mg daily

Intervention Type: DRUG

Other Intervention Names

Bupropion

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Roumen Milev

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roumen V. Milev, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Providence Care Mental Health Services

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

PSIY-219-05

Identifier Type: -

Identifier Source: org_study_id