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

This study is currently recruiting participants.
Verified December 2012 by New York State Psychiatric Institute
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01748955
First received: September 20, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Depression
Suicidal Ideation
 Drug: Paroxetine CR for Major Depressive Episode
Drug: Bupropion XL for Major Depressive Episode
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SSRI Versus Bupropion in High-Risk Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression Suicide
U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • BOLD Signal [ Time Frame: Measured at Baseline and Week 8 ] [ Designated as safety issue: No ]
    Brain activity measured during fMRI


Secondary Outcome Measures:
  • Change in suicidal ideation (SSI score) [ Time Frame: Measured at Baseline and Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: June 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Paxil CR

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748955

Contacts
Contact: Katherin Sudol, B.A. 212-543-5834 sudolka@nyspi.columbia.edu

Locations
United States, New York
Columbia University/New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Michael F. Grunebaum, M.D. Columbia University/NY State Psychiatric Institute
  More Information

Additional Information:
Click here for the Columbia University Psychiatry Clinical Trials Web site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01748955     History of Changes
Other Study ID Numbers: 5933R, K23MH076049
Study First Received: September 20, 2012
Last Updated: December 11, 2012
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Major Depressive Disorder
MDD
Reward
BOLD signal
Suicide

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Suicide
Self-Injurious Behavior
Paroxetine
Bupropion
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on May 21, 2013