NCT01748955

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4 depression

Timeline
Completed

Started Jun 2010

Typical duration for phase_4 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 15, 2017

Completed
Last Updated

November 21, 2017

Status Verified

October 1, 2017

Enrollment Period

4.8 years

First QC Date

September 20, 2012

Results QC Date

February 14, 2017

Last Update Submit

October 19, 2017

Conditions

DepressionSuicidal Ideation

Keywords

Major Depressive DisorderMDDRewardBOLD signalSuicide

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Contrast of Parameter Estimates (COPE)

    % change in COPE = (Post-treatment COPE - Pre-treatment COPE) / Pre-treatment 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 5cents vs. loses 0 cents

    Measured at Baseline (pre-treatment) and Week 8 (post-treatment)

Secondary Outcomes (1)

  • Change in Suicidal Ideation (SSI Score)

    Measured at Baseline and Week 8

Study Arms (2)

Bupropion

ACTIVE COMPARATOR

Participants will receive bupropion XL for 8 weeks.

Drug: Bupropion XL for Major Depressive Episode

paroxetine CR

ACTIVE COMPARATOR

Participants will receive Paroxetine CR for 8 weeks.

Drug: Paroxetine CR for Major Depressive Episode

Interventions

Paroxetine CR for Major Depressive EpisodeDRUG

Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment.

Also known as: Paxil CR
paroxetine CR
Bupropion XL for Major Depressive EpisodeDRUG

Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment.

Also known as: Wellbutrin XL
Bupropion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University/New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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. doi: 10.1038/npp.2011.247. Epub 2011 Oct 12.

    PMID: 21993207BACKGROUND

Related Links

MeSH Terms

Conditions

DepressionSuicidal IdeationDepressive Disorder, MajorSuicide

Interventions

ParoxetineBupropion

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-Injurious BehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropiophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
Michael F. Grunebaum, MD
Organization
New York State Psychiatric Institute
mgruneb@nyspi.columbia.edu
6467747573

Study Officials

  • Michael F. Grunebaum, M.D.

    Columbia University/NY State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

December 13, 2012

Study Start

June 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 21, 2017

Results First Posted

February 15, 2017

Record last verified: 2017-10

Locations

US(1)