Depressive IllnessPhase 4NCT03278938
Add-on to Cognitive, Event-Related Potentials (ERP) and Electroencephalogram (EEG) Asymmetry in Affective Disorders
A Phase 4 study testing bupropion and citalopram in people with Depressive Illness, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Depressed patients unremitted after monotherapy with citalopram or bupropion will remit following six weeks treatment with the combination of citalopram and bupropion. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Depressive Illness
- What is being tested?
- bupropion and citalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2012to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-remission in Protocol #6559R
- age 18-66
- signs informed consent
- physically healthy
Who cannot join
- bipolar disorder
- history of psychosis
- history of anorexia nervosa or bulimia
- history of seizure disorder, significant brain trauma or other medical reason to suspect increased seizure risk
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Add-on to Cognitive, ERP and EEG Asymmetry in Affective Disorders (#6559R) [Formerly #5723]
Depressed patients unremitted after monotherapy with citalopram or bupropion will remit following six weeks treatment with the combination of citalopram and bupropion.
Read the detailed description
Participants in another study who did not remit during 12 weeks treatment with citalopram (to 40 mg/d) or bupropion (to 450 mg/d) will have citalopram (to 40 mg/d) or bupropion (to 450 mg/d) added for six weeks.
- Conditions
- Depressive Illness
- Being tested
- bupropion, citalopram
- Keywords
- depression, citalopram, bupropion, combination therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropionDrug
Also called Wellbutrin
FDA approved drug for treating depression
citalopramDrug
Also called Celexa
FDA approved treatment for depression
| Study group | Role | What they receive |
|---|---|---|
| bupropion added to citalopram | Active comparator | patients who did not remit with citalopram will continue at the same dose and have bupropion added Receives: Drug: bupropion; Drug: citalopram |
| citalopram added to bupropion | Active comparator | Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added Receives: Drug: bupropion; Drug: citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale
Decrease in score for Hamilton Rating Scale for Depression, 17-item version
Measured: weeks 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start29 Jun 2012 (estimated)
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: PI Retired and no data was collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive IllnessStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- treatment in this study was determined by treatment received in prior study; i.e., those who had received escitalopram then receive escitalopram + bupropion; those initially taking bupropion then receive escitalopram + bupropion
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan W Stewart, MD, Principal investigator, Research Psychiatrist II at New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278938
- Sponsor's protocol ID
- #5723
- Status last verified
- Mar 2019
- First submitted
- 16 May 2013
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Add-on to Cognitive, ERP and EEG Asymmetry in Affective Disorders (#6559R) [Formerly #5723]
- ClinicalTrials.gov ID
- NCT03278938
- Acronym / sponsor ID
- #5723
- Conditions
- Depressive Illness
- Keywords
- depression, citalopram, bupropion, combination therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI Retired and no data was collected
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 29 Jun 2012 (estimated)
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Depressed patients unremitted after monotherapy with citalopram or bupropion will remit following six weeks treatment with the combination of citalopram and bupropion.
Detailed description
Participants in another study who did not remit during 12 weeks treatment with citalopram (to 40 mg/d) or bupropion (to 450 mg/d) will have citalopram (to 40 mg/d) or bupropion (to 450 mg/d) added for six weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- treatment in this study was determined by treatment received in prior study; i.e., those who had received escitalopram then receive escitalopram + bupropion; those initially taking bupropion then receive escitalopram + bupropion
| Arm | Type | Receives |
|---|---|---|
| bupropion added to citalopram | Active comparator | Drug: bupropion, Drug: citaloprampatients who did not remit with citalopram will continue at the same dose and have bupropion added |
| citalopram added to bupropion | Active comparator | Drug: bupropion, Drug: citalopramPatients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non-remission in Protocol #6559R
- age 18-66
- signs informed consent
- physically healthy
Key exclusion criteria (4 listed)
- bipolar disorder
- history of psychosis
- history of anorexia nervosa or bulimia
- history of seizure disorder, significant brain trauma or other medical reason to suspect increased seizure risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupropionAlso: WellbutrinFDA approved drug for treating depression | Drug | bupropion added to citalopram, citalopram added to bupropion |
| citalopramAlso: CelexaFDA approved treatment for depression | Drug | bupropion added to citalopram, citalopram added to bupropion |
Primary outcome
Hamilton Rating Scale
Time frame: weeks 6
Decrease in score for Hamilton Rating Scale for Depression, 17-item version
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- web site for the Depression Evaluation Service, New York State Psychiatric InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan W Stewart, MD principal investigator
Research Psychiatrist II at New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bupropion and citalopram in people with Depressive Illness, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale (time frame: weeks 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.