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

NCT00616915 | Completed Phase 1

• 1 other identifier: PSIY-219-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorder

Keywords

Wellbutrin SR

Outcome Measures

Primary Outcomes (1)

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

  pre, 3-5days, 3-4weeks after wellbutrinXL

Study Arms (1)

1

OTHER

Wellbutrin SR switched to Wellbutrin XL

Drug: Wellbutrin XL

Interventions

Wellbutrin XL DRUG

Wellbutrin XL 300mg daily

Also known as: Bupropion

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Providence Care Mental Health Services

Kingston, Ontario, L7L 4X3, Canada

Location

MeSH Terms

Conditions

Mood Disorders

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Roumen V. Milev, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2010
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

CA (1)