The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression

NCT00125957 | Completed Phase 3 Results

• 1 other identifier: 2005P-000502
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Many people with depression are treated with a serotonin-specific reuptake inhibitor anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not feel completely 'well'. Often, individuals continue to complain of cognitive problems such as lack of attention, diminished motivation, and impaired problem-solving. This study looks at whether residual and cognitive symptoms of depression in individuals are affected by the addition of Wellbutrin (bupropion).

Conditions

Depression; Major Depressive Disorder; Unipolar Depression

Keywords

depression; serotonin; norepinephrine; SSRI; Wellbutrin; bupropion; executive function; residual symptoms

Outcome Measures

Primary Outcomes (2)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  Median total depression symptoms rating at baseline and follow-up visits. The MADRS consists o 10 questions assessing depression symptoms. All questions are scored on a 0-6 severity scale, with 0 being absent and 4 being most severe. Total scores can range from 0-60.

  Baseline and follow-up

• Hamilton Depression Rating Scale (HAM-D)

  Median total depression ratings at baseline and follow-up using the HAM-D. The scale consists of 21 questions that assess depression symptoms. Questions 1-3, 7-11, 15, and 19 are rated on a scale of 0-4, with 0 being not present to and 4 being severe. Questions 4, 5, 12 - 14, 16-18 and 21 are rated from 0-2 with a score of 0 signifying the symptom is absent and a score of 2 as most severe. Item 20 is score on a scale of 0-3 with the same pattern of severity as all other questions. The total score for the HAM-D ranges from 0-63.

  Baseline and follow-up

Study Arms (2)

Wellbutrin first, then Placebo

EXPERIMENTAL

Subjects randomly assigned to the Wellbutrin then Placebo group will receive 100mg BID of Wellbutrin at the first visit following intake (Week 0).Subjects will be increased to 150mg Wellbutrin BID at Week 1 unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of bupropion qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on Wellbutrin 100mg BID. At Week 4, subjects will cross-over to placebo and will continue to take placebo until Week 8.

Drug: Wellbutrin; Drug: Placebo

Placebo first, then Wellbutrin

EXPERIMENTAL

Subjects randomly assigned to the Placebo then Wellbutrin group will receive placebo until Week 4 when they will cross-over to active drug. At Week 4, subjects will be assigned 100mg Wellbutrin BID. At Week 5, Subjects will be increased to 150mg Wellbutrin BID unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of Wellbutrin qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on bupropion 100mg BID. Subject will continue on the assigned dosage until Week 8 of study.

Drug: Wellbutrin; Drug: Placebo

Interventions

Wellbutrin DRUG

Also known as: bupropion

Placebo first, then Wellbutrin; Wellbutrin first, then Placebo

Placebo DRUG

Placebo first, then Wellbutrin; Wellbutrin first, then Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Depression
• SSRI-treated

You may not qualify if:

• Bipolar disorder
• Serotonin-norepinephrine reuptake inhibitor (SNRI) or bupropion treatment
• Treatment-resistant depression
• Seizure disorder
• Bulimia or anorexia nervosa
• Pregnancy

Sponsors & Collaborators

• Mclean Hospital: lead
• National Association for Research on Schizophrenia and Affective Disorders.: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Links

• Web site for McLean hospital with links to research.

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Depressive Disorder

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Dr. Beth Murphy
• Organization: McLean Hospital

bmurphy5@partners.org

617-855-2000

Study Officials

• Beth L Murphy, MD, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2005
• First Posted: August 2, 2005
• Study Start: August 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: December 1, 2011
• Last Updated: August 6, 2014
• Results First Posted: August 6, 2014

Record last verified: 2014-08

Locations

US (1)