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

This study is currently recruiting participants.
Verified by Queen's University, August 2008

Sponsored by: Queen's University
Information provided by: Queen's University
ClinicalTrials.gov Identifier: NCT00616915
  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 I

MedlinePlus related topics:   Depression   

ChemIDplus related topics:   Bupropion hydrochloride    Bupropion   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder?

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 ]

Estimated Enrollment:   15
Study Start Date:   January 2007
Estimated Study Completion Date:   November 2008
Estimated Primary Completion Date:   November 2008 (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

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
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

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

Contacts
Contact: Roumen Milev, MD     (613) 548-5567 ext 5857    
Contact: Judy Joannette, RN, MSc     (613) 548-5567 ext 6123     joannetj@providencecare.ca    

Locations
Canada, Ontario
Providence Care Mental Health Services     Recruiting
      Kingston, Ontario, Canada, L7L 4X3
      Contact: Roumen Milev, MD     (613) 548-5567 ext 5823        
      Contact: Judy Joannette     (613) 548-5567 ext 6123     joannetj@providencecare.ca    
      Sub-Investigator: Ruzica Jokic, MD            
      Sub-Investigator: Regina Du Toit, MD            
      Sub-Investigator: Allan Lowe, MD            

Sponsors and Collaborators
Queen's University

Investigators
Principal Investigator:     Roumen V. Milev, MD     Queen's University    
  More Information

Responsible Party:   Queen's University at Kingston ( Dr. Roumen Milev )
Study ID Numbers:   PSIY-219-05
First Received:   February 4, 2008
Last Updated:   August 19, 2008
ClinicalTrials.gov Identifier:   NCT00616915
Health Authority:   Canada: Health Canada

Keywords provided by Queen's University:
Wellbutrin SR  

Study placed in the following topic categories:
Dopamine
Depression
Mental Disorders
Bupropion
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 05, 2008




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