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

Depression Clinical Trial

Official title:

SSRI Versus Bupropion in High-Risk Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748955
• Other study ID #: 5933R
• Secondary ID: K23MH076049
• Status: Completed
• Phase: Phase 4
• First received: September 20, 2012
• Last updated: October 19, 2017
• Start date: June 2010
• Est. completion date: March 2015

Study information

• Verified date: October 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Suicidal Ideation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University/New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measured at Baseline (pre-treatment) and Week 8 (post-treatment)
Secondary	Change in Suicidal Ideation (SSI Score)	Beck Scale of Suicidal Ideation Minimum Value = 0 Maximum Value = 38 Higher score is more severe suicidal thoughts	Measured at Baseline and Week 8

External Links

•   Click here for the Columbia University Psychiatry Clinical Trials Web site
•   MIND Clinic for Mood and Personality Disorders