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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 ongoing, but not recruiting participants.
Study NCT00616915   Information provided by Queen's University
First Received: February 4, 2008   Last Updated: February 10, 2009   History of Changes

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
 
 
 
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.

Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Mood Disorder
Drug: Wellbutrin XL
Other: Wellbutrin SR switched to Wellbutrin XL
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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
Dr. Roumen Milev, Queen's University at Kingston
PSIY-219-05
Queen's University
 
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