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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University
ClinicalTrials.gov Identifier:
NCT00616915
First received: February 4, 2008
Last updated: December 14, 2015
Last verified: December 2015
  Purpose

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.


Condition Intervention Phase
Mood Disorder
Drug: Wellbutrin XL
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder?

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2007
Study Completion Date: January 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Wellbutrin SR switched to Wellbutrin XL
Drug: Wellbutrin XL
Wellbutrin XL 300mg daily
Other Name: Bupropion

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616915

Locations
Canada, Ontario
Providence Care Mental Health Services
Kingston, Ontario, Canada, L7L 4X3
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Roumen V. Milev, MD Queen's University
  More Information

Responsible Party: Dr. Roumen Milev, MD, Queen's University
ClinicalTrials.gov Identifier: NCT00616915     History of Changes
Other Study ID Numbers: PSIY-219-05 
Study First Received: February 4, 2008
Last Updated: December 14, 2015
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Wellbutrin SR

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Pathologic Processes
Mental Disorders
Behavioral Symptoms
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 08, 2016