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

Primary Purpose

Mood Disorder

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Wellbutrin XL
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Disorder focused on measuring Wellbutrin SR

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Providence Care Mental Health Services

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Wellbutrin SR switched to Wellbutrin XL

Outcomes

Primary Outcome Measures

This study is looking at the effect of Wellbutrin SR versus Wellbutrin XL on sleep quality

Secondary Outcome Measures

Full Information

First Posted
February 4, 2008
Last Updated
December 14, 2015
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT00616915
Brief Title
Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder?
Official Title
Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorder
Keywords
Wellbutrin SR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Wellbutrin SR switched to Wellbutrin XL
Intervention Type
Drug
Intervention Name(s)
Wellbutrin XL
Other Intervention Name(s)
Bupropion
Intervention Description
Wellbutrin XL 300mg daily
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Signed Patient Informed Consent; Patients with Major Depressive Disorders (DSM-IV-TR - criteria used); Out-patients; Males or females over 18 years of age; Patients currently using Wellbutrin SR. Exclusion Criteria: Bipolar Disorder patients; Actively suicidal patients; Schizophrenia, Schizoaffective or other Psychotic Disorder; Pregnant women, as by pregnancy test at the beginning of the study; Women in childbearing age, refusing to use appropriate contraception, or breastfeeding mothers; Patients with known hypersensitivity to bupropion; Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety; ECT or TMS treatments within the last three months; Patients who did not respond to previous treatment with bupropion; Patients with history of seizure disorder; Patients with history of eating disorders (e.g. bulimia, anorexia nervosa); Patients using sleep aiding medication (Benzodiazepines, barbiturates).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roumen V. Milev, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Care Mental Health Services
City
Kingston
State/Province
Ontario
ZIP/Postal Code
L7L 4X3
Country
Canada

12. IPD Sharing Statement

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

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