Trial · NCT00429169

Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression

NCT00429169, Phase 4, Terminated, New York State Psychiatric Institute; results first posted 2013-01-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression. Trials, record NCT00429169. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00429169

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression
NCT number: NCT00429169
Status: Terminated
Phases: Phase 4
Enrollment: 101 participants, actual
Lead sponsor: New York State Psychiatric Institute
Conditions: Depression
Interventions: Paroxetine, Bupropion
First posted: 2007-01-31
Last updated: 2018-10-30
Results first posted: 2013-01-24
Limitations and caveats: 1. Significant dropout meant the number of subjects with analyzable data was smaller than the number enrolled.~2. An interim analysis of this pilot study showed differential treatment effects so a decision was made to stop enrollment early.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Go-No go Test	Measured at Baseline and Week 8	Change in neuropsychological measure of impulsivity. Computer-based task involving induction of a dominant response tendency and testing of the subject's ability to withhold responding to less frequent non-target stimuli.
Primary	Scale for Suicidal Ideation	Baseline and Week 8	The clinician-rated Beck Scale for Suicidal Ideation (SSI) (Beck et al 1979)was used weekly for 8 weeks. It has 19 items scaled 0 (least severe) to 2 (most severe) and total score is the sum, ranging 0 to 38 (Beck et al 1979). Items measure frequency, intensity, and attitudes toward suicidal thoughts, feelings of control over them, and suicide plans. Mean score in 90 inpatients hospitalized for suicidal ideation was 9.4±8.4, versus 4.4±5.8 in outpatients as cited in the study by Beck et al, 1979.
Primary	Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment	Measured at Month 6	Suicide attempts, other suicidal behavior, or increase in suicidal thoughts that required a change in clinical treatment.
Primary	Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task.	Baseline and Week 8.	Comparison of fMRI results at baseline and after 8 weeks of antidepressant pharmacotherapy with paroxetine vs. bupropion. Percent change in contrast of parameter estimates (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 5 cents vs. loses 0 cents

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Go-No go Test	Measured at Baseline and Week 8	These were the number with analyzable data	Commission errors	MEAN
PRIMARY	Scale for Suicidal Ideation	Baseline and Week 8	The study was powered for N=50 subjects per group based on naturalistic pilot data from our clinic. An interim data analysis showed an interaction of treatment with baseline suicidal ideation severity on follow-up ideation. After consulting with clinical colleagues, statisticians and the IRB, a decision was made to stop enrollment.	Points on Scale for Suicidal Ideation	MEAN
PRIMARY	Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment	Measured at Month 6	These were the number of subjects with analyzable data.	Events	NUMBER
PRIMARY	Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task.	Baseline and Week 8.	Major depressive disorder with suicidal thoughts or past suicide attempt.	percentage of change in COPE	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Go-No go Test	Paroxetine		-0.09	Standard Deviation 0.8	Commission errors
Go-No go Test	Bupropion		-0.06	Standard Deviation 0.89	Commission errors
Scale for Suicidal Ideation	Paroxetine	Baseline	8.0	Standard Deviation 6.7	Points on Scale for Suicidal Ideation
Scale for Suicidal Ideation	Bupropion	Baseline	9.9	Standard Deviation 7.4	Points on Scale for Suicidal Ideation
Scale for Suicidal Ideation	Paroxetine	Week 8	2.3	Standard Deviation 4.5	Points on Scale for Suicidal Ideation
Scale for Suicidal Ideation	Bupropion	Week 8	4.7	Standard Deviation 6.6	Points on Scale for Suicidal Ideation
Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment	Paroxetine		4		Events
Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment	Bupropion		6		Events
Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task.	Paroxetine		-0.27	Full Range -0.59 to 2.9	percentage of change in COPE
Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task.	Bupropion		-0.95	Full Range -1.3 to 1.7	percentage of change in COPE

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Paroxetine	38
Overall Study	STARTED	Bupropion	40
Overall Study	COMPLETED	Paroxetine	36
Overall Study	COMPLETED	Bupropion	38
Overall Study	NOT COMPLETED	Paroxetine	2
Overall Study	NOT COMPLETED	Bupropion	2

Source ClinicalTrials.gov

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Suicide attempt by acetaminophen overdose	Hepatobiliary disorders	Paroxetine	1	36	1
serious	Suicide attempt by acetaminophen overdose	Hepatobiliary disorders	Bupropion	0	38	0
serious	Increased suicidal thoughts causing admission to hospital	Nervous system disorders	Paroxetine	2	36	2
serious	Increased suicidal thoughts causing admission to hospital	Nervous system disorders	Bupropion	2	38	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Paroxetine
Total, all-cause mortality	Bupropion
Total, other adverse events	Paroxetine	0	36
Total, other adverse events	Bupropion	0	38
Total, serious adverse events	Paroxetine	3	36
Total, serious adverse events	Bupropion	2	38

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21993207	RESULT	PubMed
24107760	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
K23MH076049	Paroxetine/Bupropion in Suicide Attempters/Ideators with Major Depression	GRUNEBAUM, MICHAEL F	COLUMBIA UNIVERSITY HEALTH SCIENCES	NATIONAL INSTITUTE OF MENTAL HEALTH	2006 to 2010

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Paroxetine vs Bupropion: serious adverse events

Source Trial comparisons

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Go/No-Go Task	Primary outcome	ConductCognition
Monetary Incentive Delay	Primary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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