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

Completed · Phase 4

Conditions studied: Depression, Suicidal Ideation

In brief

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.

Key facts

Study ID

NCT01748955

Run by

New York State Psychiatric Institute

People needed

15

Starts

2010-06-01

Expected to finish

2015-03-01

Last updated by the study team

2017-11-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Columbia University/New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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