Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression - Full Text View

Sponsor:	New York State Psychiatric Institute
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00429169

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: Paroxetine CR for major depressive episode Drug: Bupropion XL for major depressive episode	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Paroxetine Versus Bupropion for Suicide Ideators or Attempters With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression Suicide

Drug Information available for: Bupropion hydrochloride Bupropion Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Paroxetine Mesylate

U.S. FDA Resources

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

Primary Outcome Measures:

Reduction in neuropsychological measures of impulsivity [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Reduction in suicidal ideation [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ]
Occurrence of suicidal ideation or acts necessitating a change in treatment [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Brain activity measured by BOLD signal with fMRI during a reward processing task. [ Time Frame: Baseline and Week 8. ] [ Designated as safety issue: No ]
Comparison of fMRI results at baseline and after 8 weeks of antidepressant pharmacotherapy with paroxetine vs. bupropion.

Estimated Enrollment:	125
Study Start Date:	June 2004
Estimated Study Completion Date:	January 2013
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Participants will receive paroxetine for 8 weeks	Drug: Paroxetine CR for major depressive episode Dosage will be 25 mg every day for 2 weeks, then 37.5 mg every day for 2 weeks, and then optional increase to 50 mg every day for the remainder of treatment. Other Name: Paxil CR
Active Comparator: 2 Participants will receive bupropion for 8 weeks	Drug: Bupropion XL for major depressive episode Dosage will be 150 mg every day for 2 weeks, then 300 mg every day for 2 weeks, and then optional increase to 450 mg every day for the remainder of treatment. Other Name: Wellbutrin XL

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. Selective serotonin reuptake inhibitors (SSRIs) are a type of antidepressant medication that works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance. The study compared the effectiveness of paroxetine, an SSRI, versus bupropion, a non-SSRI, on suicidal ideation and/or behavior in depressed patients with a past suicide attempt and/or current suicidal thoughts. Results of the completed primary study have been published (Grunebaum MF et al. Neuropsychopharmacology. 2012 Feb;37(3):697-706).

In the ongoing secondary neuro-imaging component of the study, 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:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429169

Contacts

Contact: Katherin Sudol, BA

212-543-5834

sudolka@nyspi.columbia.edu

Locations

United States, New York
Columbia University/New York State Psychiatric Institute	Recruiting
New York City, New York, United States, 10032
Contact: Kat Sudol, BA 212-543-5834 sudolka@nyspi.columbia.edu
Contact: , BA
Principal Investigator: Michael F. Grunebaum, MD

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Michael F. Grunebaum, MD

Columbia University/New York State Psychiatric Institute

More Information

Publications:

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. Epub 2011 Oct 12.

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00429169 History of Changes
Other Study ID Numbers:	#5933R, K23MH076049, DSIR 8KRT-AT
Study First Received:	January 29, 2007
Last Updated:	February 3, 2012
Health Authority:	United States: Federal Government

Keywords provided by New York State Psychiatric Institute:

Major Depressive Disorder
MDD

Additional relevant MeSH terms:

Depression
Depressive Disorder
Suicide
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
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 February 12, 2012