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

Primary Purpose

Depression, Suicidal Ideation

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Paroxetine CR for Major Depressive Episode

Bupropion XL for Major Depressive Episode

About this trial

This is an interventional treatment trial for Depression focused on measuring Major Depressive Disorder, MDD, Reward, BOLD signal, Suicide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient suffering from an episode of major depressive disorder (MDD)
Age range 18-65 years
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.
Patients 60 years of age and older must score at least 25 on MMSE at screening.
Patients 60 years of age and older must have a normal ECG within the past year.

Exclusion Criteria:

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).
Primary disorder is an anxiety disorder such as Panic disorder/GAD/OCD/ Social anxiety disorder, with secondary depression.
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.
Blood pressure reading ≥ 140/90
Active and/or unstable medical problems including a significant risk for seizures
Antipsychotic medication required
Patients who have become hypomanic or manic on antidepressants
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.
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).
Lacks capacity to consent
Pregnancy, lactation, or plans to conceive during the course of study participation.
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.
Patients with ferrous metal implants in their bodies, or a history of claustrophobia that precludes MRI, will be excluded.
Patients assessed as being unlikely to tolerate the maximum 2-week delay to start of treatment.

Sites / Locations

Columbia University/New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Bupropion

paroxetine CR

Arm Description

Participants will receive bupropion XL for 8 weeks.

Participants will receive Paroxetine CR for 8 weeks.

Outcomes

Primary Outcome Measures

Percent Change in Contrast of Parameter Estimates (COPE)

% 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

Secondary Outcome Measures

Change in Suicidal Ideation (SSI Score)

Beck Scale of Suicidal Ideation Minimum Value = 0 Maximum Value = 38 Higher score is more severe suicidal thoughts

Full Information

NCT ID

NCT01748955

First Posted

September 20, 2012

Last Updated

October 19, 2017

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01748955

Brief Title

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

Official Title

SSRI Versus Bupropion in High-Risk Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Suicidal Ideation

Keywords

Major Depressive Disorder, MDD, Reward, BOLD signal, Suicide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bupropion

Arm Type

Active Comparator

Arm Description

Participants will receive bupropion XL for 8 weeks.

Arm Title

paroxetine CR

Arm Type

Active Comparator

Arm Description

Participants will receive Paroxetine CR for 8 weeks.

Intervention Type

Drug

Intervention Name(s)

Paroxetine CR for Major Depressive Episode

Other Intervention Name(s)

Paxil CR

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Bupropion XL for Major Depressive Episode

Other Intervention Name(s)

Wellbutrin XL

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percent Change in Contrast of Parameter Estimates (COPE)

Description

Time Frame

Measured at Baseline (pre-treatment) and Week 8 (post-treatment)

Secondary Outcome Measure Information:

Title

Change in Suicidal Ideation (SSI Score)

Description

Beck Scale of Suicidal Ideation Minimum Value = 0 Maximum Value = 38 Higher score is more severe suicidal thoughts

Time Frame

Measured at Baseline and Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient suffering from an episode of major depressive disorder (MDD) Age range 18-65 years 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. Patients 60 years of age and older must score at least 25 on MMSE at screening. Patients 60 years of age and older must have a normal ECG within the past year. Exclusion Criteria: 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). Primary disorder is an anxiety disorder such as Panic disorder/GAD/OCD/ Social anxiety disorder, with secondary depression. 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. Blood pressure reading ≥ 140/90 Active and/or unstable medical problems including a significant risk for seizures Antipsychotic medication required Patients who have become hypomanic or manic on antidepressants 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. 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). Lacks capacity to consent Pregnancy, lactation, or plans to conceive during the course of study participation. 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. Patients with ferrous metal implants in their bodies, or a history of claustrophobia that precludes MRI, will be excluded. Patients assessed as being unlikely to tolerate the maximum 2-week delay to start of treatment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael F. Grunebaum, M.D.

Organizational Affiliation

Columbia University/NY State Psychiatric Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University/New York State Psychiatric Institute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21993207

Citation

Grunebaum MF, Ellis SP, Duan N, Burke AK, Oquendo MA, John Mann J. Pilot randomized clinical trial of an SSRI vs bupropion: effects on suicidal behavior, ideation, and mood in major depression. Neuropsychopharmacology. 2012 Feb;37(3):697-706. doi: 10.1038/npp.2011.247. Epub 2011 Oct 12.

Results Reference

background

Links:

URL

http://columbiapsychiatry.org/clinical-trials

Description

Click here for the Columbia University Psychiatry Clinical Trials Web site

URL

http://www.columbiapsychiatry.org/mind/

Description

MIND Clinic for Mood and Personality Disorders

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

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