DepressionPhase 4NCT01748955
Paroxetine/Bupropion in Depression With Suicide Attempt or Thoughts: fMRI Study
A Phase 4 study testing Paroxetine CR for Major Depressive Episode and Bupropion XL for Major Depressive Episode in people with Depression and Suicidal Ideation, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Suicidal Ideation
- What is being tested?
- Paroxetine CR for Major Depressive Episode and Bupropion XL for Major Depressive Episode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Mar 2015
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Patients who have become hypomanic or manic on antidepressants
- Contraindication to the use of an SSRI or bupropion, or currently using Zyban. Anorexia nervosa in remission at least one year is not an exclusion.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University/New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: SSRI Versus Bupropion in High-Risk Major Depressive Disorder
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.
Read the 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.
The study uses functional magnetic resonance imaging (fMRI) to compare the effects of paroxetine, an SSRI, versus bupropion, a non-SSRI, on brain activity in depressed patients with a past suicide attempt and/or current suicidal thoughts. 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.
- Conditions
- Depression, Suicidal Ideation
- Being tested
- Paroxetine CR for Major Depressive Episode, Bupropion XL for Major Depressive Episode
- Keywords
- Major Depressive Disorder, MDD, Reward, BOLD signal, Suicide
- Medical subject headings
- Depression, Suicidal Ideation, Depressive Disorder, Major, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paroxetine CR for Major Depressive EpisodeDrug
Also called Paxil CR
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.
Bupropion XL for Major Depressive EpisodeDrug
Also called Wellbutrin XL
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.
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Active comparator | Participants will receive bupropion XL for 8 weeks. Receives: Drug: Bupropion XL for Major Depressive Episode |
| paroxetine CR | Active comparator | Participants will receive Paroxetine CR for 8 weeks. Receives: Drug: Paroxetine CR for Major Depressive Episode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Baseline (pre-treatment) and Week 8 (post-treatment)
Secondary outcomes (1)
Change in Suicidal Ideation (SSI Score)
Beck Scale of Suicidal Ideation Minimum Value = 0 Maximum Value = 38 Higher score is more severe suicidal thoughts
Measured: Measured at Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startJun 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Michael F. Grunebaum, M.D., Principal investigator, Columbia University/NY State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748955
- Sponsor's protocol ID
- 5933R
- Other IDs
- K23MH076049
- Status last verified
- Oct 2017
- First submitted
- 20 Sep 2012
- Last updated
- 21 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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. doi: 10.1038/npp.2011.247. Epub 2011 Oct 12.
PubMed 21993207