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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01748955
Recruitment Status : Completed
First Posted : December 13, 2012
Results First Posted : February 15, 2017
Last Update Posted : November 21, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SSRI Versus Bupropion in High-Risk Major Depressive Disorder
Study Start Date : June 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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 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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01748955

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

Additional Information:
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Responsible Party: New York State Psychiatric Institute Identifier: NCT01748955    
Other Study ID Numbers: 5933R
K23MH076049 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2012    Key Record Dates
Results First Posted: February 15, 2017
Last Update Posted: November 21, 2017
Last Verified: October 2017
Keywords provided by New York State Psychiatric Institute:
Major Depressive Disorder
BOLD signal
Additional relevant MeSH terms:
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Depressive Disorder
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Self-Injurious Behavior
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Uptake Inhibitors
Serotonin Agents