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

NCT ID: NCT01748955

Last Updated: 2017-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-03-31

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.

Conditions

Depression; Suicidal Ideation

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bupropion

Participants will receive bupropion XL for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Bupropion XL for Major Depressive Episode

Intervention Type: DRUG

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.

paroxetine CR

Participants will receive Paroxetine CR for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Paroxetine CR for Major Depressive Episode

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Paxil CR; Wellbutrin XL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael F. Grunebaum, M.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University/NY State Psychiatric Institute

Locations

Columbia University/New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21993207 (View on PubMed)

Related Links

http://columbiapsychiatry.org/clinical-trials

Click here for the Columbia University Psychiatry Clinical Trials Web site

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

MIND Clinic for Mood and Personality Disorders

Other Identifiers

K23MH076049

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5933R

Identifier Type: -

Identifier Source: org_study_id