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

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00429169

Purpose

This study will compare the effectiveness of two antidepressant medications in treating depression in people who have attempted suicide or are currently experiencing suicidal ideation.

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

MedlinePlus related topics: Depression Suicide

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

U.S. FDA Resources

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

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:	100
Study Start Date:	June 2004
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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.

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 that is most commonly associated with suicide. The treatment of MDD with antidepressant medication, however, remains a process based largely on trial and error. In particular, little empirical evidence exists to guide the treatment of MDD when suicide 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. This study will compare the effectiveness of paroxetine, an SSRI antidepressant, versus bupropion, a non-SSRI antidepressant, in treating depression in people who have attempted suicide or are currently experiencing suicidal ideation.

Participants in this double-blind study will be randomly assigned to receive either paroxetine or bupropion for 8 weeks. Weekly study visits will include interviews with a psychologist, self-report scales, and medication monitoring. All participants will then be offered 4 additional months of open label treatment with their assigned medications, and study visits will occur at least monthly. If original medication assignments prove to be ineffective, participants will have the option to switch to another medication, which, in most cases, will be the other study medication. After completing the 6-month study, participants will be referred for ongoing treatment at another clinic, but will continue attending clinical follow up visits at the study site until their new care has been established.

Eligibility

Ages Eligible for Study:	18 Years to 75 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.

Exclusion Criteria:

Any of the following conditions: bipolar disorder; current psychotic symptoms; past or current bulimia or anorexia nervosa or purging behavior occurring, on average, at least twice a week for 3 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 150 mm Hg or diastolic blood pressure greater than 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 pulsed dose rate [PDR] dose 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

Contacts and Locations

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

Contacts

Contact: Lucia Sanchez, BA	212-543-6216	sanchel@pi.cpmc.columbia.edu
Contact: Jason Turret, BA	212-543-5834	turretj@pi.cpmc.columbia.edu

Locations

United States, New York
Columbia University/New York State Psychiatric Institute	Recruiting
New York City, New York, United States, 10032
Contact: Lucia Sanchez, BA 212-543-6216 sanchel@pi.cpmc.columbia.edu
Contact: Jason Turret, BA 212-543-5834 turretj@pi.cpmc.columbia.edu
Principal Investigator: Michael F. Grunebaum, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Michael F. Grunebaum, MD

Columbia University/New York State Psychiatric Institute

More Information

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

Responsible Party:	Columbia University and New York State Psychiatric Institute ( Michael F. Grunebaum, MD )
Study ID Numbers:	K23 MH76049, DSIR 8KRT-AT
Study First Received:	January 29, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00429169
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Major Depressive Disorder
MDD

Study placed in the following topic categories:

Dopamine
Depression
Mental Disorders
Bupropion
Mood Disorders
Suicide

Depressive Disorder, Major
Depressive Disorder
Paroxetine
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 30, 2009