Major DepressionPhase 4NCT00296712
Are Two Antidepressants a Good Initial Treatment for Depression?
A Phase 4 study testing escitalopram + bupropion in people with Major Depression and Dysthymia, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Relatively drug naive patients will receive two antidepressant medications as initial treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression, Dysthymia, Depression NOS
- What is being tested?
- escitalopram + bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jul 2006
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently depressed (DSM-IV Major Depression, Dysthymia or Depression NOS)
- HAMD-D (21-Item) > 9
Who cannot join
- Prior ineffective adequate trial on either study medication ($ 4 weeks on either escitalopram >20 mg/d or bupropion >300 mg/d; >4 weeks on citalopram >40 mg/d)
- History suggesting increased risk for Seizures (e.g., prior Seizure as an adult, diagnosed Seizure Disorder, taking medication known to increase seizure risk, history of significant head trauma, history of Bulimia or Anorexia)
- History of intolerance to either study medication unless patient and M.D. agree side effect is probably manageable
- Alcohol and/or drug abuse/dependence during past year
- Major medical problems that are not well controlled (e.g., untreated hypertension or diabetes)
- Bipolar I, Bipolar II
Show all 12Show fewer
- History of Psychosis, or current Psychosis
- Currently taking antidepressants or mood stabilizers, which is judged unwise to discontinue (occasional sleep medication or benzodiazepine for Anxiety is allowed)
- Not currently depressed (whether considered due to current treatment or not)
- Active suicidal risk (history of suicide attempts will be evaluated on a case by case basis)
- Pregnant or breast-feeding
- Premenopausal women not using known effective birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.
Relatively drug naive patients will receive two antidepressant medications as initial treatment.
Read the detailed description
While antidepressant medications are often effective in relieving depressive symptoms, at least 60% of patients do not remit with the first agent tried. This pilot study will assess whether giving two standard medications simultaneously (i.e., Escitalopram and Bupropion) is both tolerated and improves response while decreasing drop outs. This is a replication of a previous study.
- Conditions
- Major Depression, Dysthymia, Depression NOS
- Being tested
- escitalopram + bupropion
- Keywords
- Major Depression, Dysthymia, Depression NOS, Escitalopram, Bupropion, Dual Therapy, Combination Therapy
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopram + bupropionDrug
Also called escitalopram = Lexapro, bupropion = Wellbutrin
same dosing as for monotherapy arms
| Study group | Role | What they receive |
|---|---|---|
| escitalopram + bupropion | Experimental | patients begin on escitalopram 10 mg/d, then bupropion 150 mg/d is added and each is alternately increased as tolerated to maximal dose of escitalopram of 40 mg/d and of bupropion of 450 mg/d Receives: Drug: escitalopram + bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (HAM-D)
Measured: 10 weeks
Secondary outcomes (4)
Beck Depression Inventory (BDI)
Measured: 10 weeks
Clinical Global Impression Scale (CGI)
Measured: 10 weeks
Patient Global Impression Scale (PGI)
Measured: 10 weeks
Arizona Sexual Experience Scale (ASEX)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startFeb 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 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, New York State Psychiatric Institute - Columbia University Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296712
- Sponsor's protocol ID
- #4653
- Status last verified
- Apr 2012
- First submitted
- 24 Feb 2006
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Stewart JW, McGrath PJ, Deliyannides RA, Quitkin FM. Does dual antidepressant therapy as initial treatment hasten and increase remission from depression? J Psychiatr Pract. 2009 Sep;15(5):337-45. doi: 10.1097/01.pra.0000361276.88339.44.
PubMed 19820552
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.
- ClinicalTrials.gov ID
- NCT00296712
- Acronym / sponsor ID
- #4653
- Conditions
- Major Depression, Dysthymia, Depression NOS
- Keywords
- Major Depression, Dysthymia, Depression NOS, Escitalopram, Bupropion, Dual Therapy, Combination Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 27 Feb 2006 (estimated)
- 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.
Relatively drug naive patients will receive two antidepressant medications as initial treatment.
Detailed description
While antidepressant medications are often effective in relieving depressive symptoms, at least 60% of patients do not remit with the first agent tried. This pilot study will assess whether giving two standard medications simultaneously (i.e., Escitalopram and Bupropion) is both tolerated and improves response while decreasing drop outs. This is a replication of a previous study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| escitalopram + bupropion | Experimental | Drug: escitalopram + bupropionpatients begin on escitalopram 10 mg/d, then bupropion 150 mg/d is added and each is alternately increased as tolerated to maximal dose of escitalopram of 40 mg/d and of bupropion of 450 mg/d |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently depressed (DSM-IV Major Depression, Dysthymia or Depression NOS)
- HAMD-D (21-Item) > 9
Key exclusion criteria (12 listed)
- Prior ineffective adequate trial on either study medication ($ 4 weeks on either escitalopram >20 mg/d or bupropion >300 mg/d; >4 weeks on citalopram >40 mg/d)
- History suggesting increased risk for Seizures (e.g., prior Seizure as an adult, diagnosed Seizure Disorder, taking medication known to increase seizure risk, history of significant head trauma, history of Bulimia or Anorexia)
- History of intolerance to either study medication unless patient and M.D. agree side effect is probably manageable
- Alcohol and/or drug abuse/dependence during past year
- Major medical problems that are not well controlled (e.g., untreated hypertension or diabetes)
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 |
|---|---|---|
| escitalopram + bupropionAlso: escitalopram = Lexapro, bupropion = Wellbutrinsame dosing as for monotherapy arms | Drug | escitalopram + bupropion |
Primary outcome
Hamilton Depression Scale (HAM-D)
Time frame: 10 weeks
4 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: 10 weeks
Clinical Global Impression Scale (CGI)
Time frame: 10 weeks
Patient Global Impression Scale (PGI)
Time frame: 10 weeks
Arizona Sexual Experience Scale (ASEX)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
- Derived from this study: PubMed 19820552Stewart JW, McGrath PJ, Deliyannides RA, Quitkin FM. Does dual antidepressant therapy as initial treatment hasten and increase remission from depression? J Psychiatr Pract. 2009 Sep;15(5):337-45. doi: 10.1097/01.pra.0000361276.88339.44.
- Depression Evaluation Service - official websiteLink provided by the sponsor.
- New York State Psychiatric Institute - official websiteLink 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
New York State Psychiatric Institute - Columbia University Department of Psychiatry
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 escitalopram + bupropion in people with Major Depression and Dysthymia, 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 27 Apr 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Depression Scale (HAM-D) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00296712, which also lists 1 linked publication.
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 27 Apr 2012.