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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Queen's University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00616915
First received: February 4, 2008
Last updated: February 10, 2009
Last verified: February 2009

February 4, 2008
February 10, 2009
January 2007
January 2009   (final data collection date for primary outcome measure)
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 ]
This study is looking at the effect of Wellbutrin SR versus Wellbutrin XL on sleep quality [ Time Frame: April 2008 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00616915 on ClinicalTrials.gov Archive Site
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Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder?
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mood Disorder
Drug: Wellbutrin XL
Wellbutrin XL 300mg daily
Other Name: Bupropion
1
Wellbutrin SR switched to Wellbutrin XL
Intervention: Drug: Wellbutrin XL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
January 2010
January 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00616915
PSIY-219-05
No
Dr. Roumen Milev, Queen's University at Kingston
Queen's University
Not Provided
Principal Investigator: Roumen V. Milev, MD Queen's University
Queen's University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP