Paroxetine/Bupropion in Depression With Suicide Attempt or Thoughts: fMRI Study

October 19, 2017 updated by: New York State Psychiatric Institute

SSRI Versus Bupropion in High-Risk Major Depressive Disorder

This study uses functional magnetic resonance imaging (fMRI) to investigate the effects of two different antidepressant medications (Paxil CR versus Wellbutrin XL) on reward processing in depressed patients who have attempted suicide or are currently experiencing suicidal thoughts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Major depressive disorder (MDD) is a common and serious psychiatric illness. It is among the leading causes of disability and is the psychiatric disorder most often associated with suicide. The treatment of MDD with antidepressant medication remains largely trial and error. Little empirical evidence exists to guide the treatment of MDD when suicide risk is a major factor.

The study uses functional magnetic resonance imaging (fMRI) to compare the effects of paroxetine, an SSRI, versus bupropion, a non-SSRI, on brain activity in depressed patients with a past suicide attempt and/or current suicidal thoughts. Participants are randomly assigned to either paroxetine or bupropion treatment for 8 weeks, with fMRI scans involving a reward processing task at baseline and Week 8. Weekly study visits include interviews with a psychologist, self-report scales, and medication monitoring. All participants will then be offered 4 additional months of open clinical treatment. If original medication assignments prove to be ineffective, participants will have the option to switch to another medication. After completing the study, participants will be referred for ongoing treatment.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University/New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient suffering from an episode of major depressive disorder (MDD)
  2. Age range 18-65 years
  3. History of a past suicide attempt or score > 2 on HDRS item #3 (suicide) at in-person screening interview. Patients with suicidal plan or intent will only be enrolled as inpatients if independent inpatient treatment team agrees with the plan to enroll the patient.
  4. Patients 60 years of age and older must score at least 25 on MMSE at screening.
  5. Patients 60 years of age and older must have a normal ECG within the past year.

Exclusion Criteria:

  1. Bipolar disorder; current psychotic symptoms; bulimia or anorexia that is current or within the past year, or current purging at least twice a week for three months; persons already taking SSRIs or bupropion for other indications (such as anxiety disorders).
  2. Primary disorder is an anxiety disorder such as Panic disorder/GAD/OCD/ Social anxiety disorder, with secondary depression.
  3. Drug or alcohol dependence within past six months; persons with current drug or alcohol abuse may be enrolled if this is assessed as being of lesser importance than the major depressive episode.
  4. Blood pressure reading ≥ 140/90
  5. Active and/or unstable medical problems including a significant risk for seizures
  6. Antipsychotic medication required
  7. Patients who have become hypomanic or manic on antidepressants
  8. Contraindication to the use of an SSRI or bupropion, or currently using Zyban. Anorexia nervosa in remission at least one year is not an exclusion.
  9. Failure to respond to adequate trials of 3 SSRIs or paroxetine or bupropion in the last 2 years (failure to respond to therapeutic trial defined as: at least 2/3 maximal PDR dose for at least 6 weeks).
  10. Lacks capacity to consent
  11. Pregnancy, lactation, or plans to conceive during the course of study participation.
  12. Patients currently on effective treatment, who require adjunctive antipsychotic or mood stabilizing medication, or who are unlikely to respond to single agent treatment for depression will be excluded.
  13. Patients with ferrous metal implants in their bodies, or a history of claustrophobia that precludes MRI, will be excluded.
  14. Patients assessed as being unlikely to tolerate the maximum 2-week delay to start of treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupropion
Participants will receive bupropion XL for 8 weeks.
Drug: Bupropion XL for Major Depressive Episode
Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment.
Other Names:
  • Wellbutrin XL
Active Comparator: paroxetine CR
Participants will receive Paroxetine CR for 8 weeks.
Drug: Paroxetine CR for Major Depressive Episode
Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment.
Other Names:
  • Paxil CR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Contrast of Parameter Estimates (COPE)
Time Frame: Measured at Baseline (pre-treatment) and Week 8 (post-treatment)

% change in COPE = (Post-treatment COPE - Pre-treatment COPE) / Pre-treatment COPE COPE is measured during Monetary Incentive Delay Task.

Task conditions are:

Reward= BOLD signal when subject wins 5 cents vs. wins 0 cents Punishment= BOLD signal when subject loses 5cents vs. loses 0 cents
Measured at Baseline (pre-treatment) and Week 8 (post-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Suicidal Ideation (SSI Score)
Time Frame: Measured at Baseline and Week 8
Beck Scale of Suicidal Ideation Minimum Value = 0 Maximum Value = 38 Higher score is more severe suicidal thoughts
Measured at Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Michael F. Grunebaum, M.D., Columbia University/NY State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 20, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 13, 2012

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5933R
  • K23MH076049 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Bupropion XL for Major Depressive Episode

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe