Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression

Stopped early · Phase 4

Conditions studied: Depression

In brief

The primary study comparing effectiveness for suicidal ideation and/or behavior of two antidepressant medications in depressed patients who have attempted suicide or are currently experiencing suicidal thoughts has been completed. A secondary study component using functional magnetic resonance imaging (fMRI) to investigate different medication effects on reward processing in the same sample is ongoing.

Key facts

Study ID

NCT00429169

Run by

New York State Psychiatric Institute

People needed

101

Starts

2004-06-01

Expected to finish

2013-01-01

Last updated by the study team

2018-10-30

Who can join

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

You may qualify if…

• Currently suffering from a major depressive episode (unipolar only)
• History of a past suicide attempt or score greater than 2 on the Hamilton Depression Rating Scale (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.
• 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…

• Any of the following conditions: 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; already taking selective serotonin reuptake inhibitors (SSRIs) or bupropion for other indications (such as anxiety disorders)
• Primary disorder is an anxiety disorder (e.g., panic disorder, general anxiety disorder, obsessive compulsive disorder, social anxiety disorder), with secondary depression
• Drug or alcohol dependence within 6 months prior to study entry (current drug or alcohol abuse may be permitted if study officials determine that the abuse is of lesser importance than the major depressive episode)
• Systolic blood pressure greater than or equal to 140 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg
• Significant active physical illness, particularly those that may affect the brain or serotonergic system (e.g., blood dyscrasias lymphomas, hypersplenism, endocrinopathies, kidney failure, severe chronic obstructive lung disease, autonomic neuropathies, active malignancy)
• Active medical problems
• Requires antipsychotic medication
• History of hypomania or mania while taking antidepressants
• Any condition that may make the use of an SSRI or bupropion medically inadvisable
• Currently using Zyban
• Failure to respond to adequate trials of three SSRIs, paroxetine, or bupropion within 2 years prior to study entry (failure to respond to therapeutic trial defined as at least 2/3 maximal daily dose [PDR] for at least 6 weeks)
• Pregnant, breastfeeding, or plans to become pregnant during the course of study participation
• Currently on effective treatment, requires adjunctive antipsychotic or mood stabilizing medication, or is unlikely to respond to single agent treatment for depression
• 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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