Major Depressive DisorderPhase 4CO-MEDNCT00590863
Combining Medications to Enhance Depression Outcomes
A Phase 4 study testing Escitalopram + Bupropion SR and Venlafaxine XR + Mirtazapine in people with Major Depressive Disorder, run by National Institute of Mental Health (NIMH) at 15 sites in United States.
Trial summary
This study will compare whether a combination of antidepressant medications is better than one antidepressant medication alone when given as initial treatment for people with chronic or recurrent major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram + Bupropion SR and Venlafaxine XR + Mirtazapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 665 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seeking treatment at the primary or specialty care site, and be planning to continue living in the area of that clinic for the duration of the study
- Meets clinical criteria for nonpsychotic MDD, recurrent (with the current episode being at least 2 months in duration), or chronic (current episode greater than 2 years) as defined by a clinical interview and confirmed by the MINI International Neuropsychiatric Interview (MINI)
- Screening 17 item HRSD score of 16 or greater
- Treatment with antidepressant medication combinations is clinically acceptable
- Patient with and without current suicidal ideation may be included in the study as long as outpatient treatment is clinically appropriate
Who cannot join
- Pregnant or breastfeeding
- Plans to become pregnant over the ensuing 8 months following study entry or are sexually active and not using adequate birth control
- History (lifetime) of psychotic depression, schizophrenia, bipolar (I, II, or NOS), schizoaffective, or other Axis I psychotic disorders
- Current psychotic symptom(s)
- History (within the last 2 years before study entry) of anorexia or bulimia
- Current primary diagnosis of obsessive compulsive disorder
Show all 24Show fewer
- Current substance dependence that requires inpatient detoxification or inpatient treatment
- Requiring immediate hospitalization for a psychiatric disorder
- Definite history of intolerance or allergy (lifetime) to any protocol medication
- History of clear nonresponse to an adequate trial of an FDA-approved monotherapy in the current MDE if recurrent, or during the last 2 years before study entry if chronic
- History of clear nonresponse to an adequate trial of any study medication used as a monotherapy, or to one or more of the protocol combinations in the current or any prior MDE
- Currently taking any of the study medications at any dose
- Having taken Prozac (fluoxetine) or an MAOI in the 4 weeks before study entry
- Presence of an unstable general medical condition (GMC) that will likely require hospitalization or to be deemed terminal (life expectancy less than 6 months after study entry)
- Currently taking medications or have GMCs that contraindicate any study medications (e.g., seizure disorder)
- Requiring medications for GMCs that contraindicate any study medication
- Epilepsy or other conditions requiring an anticonvulsant
- Lifetime history of having a seizure including febrile or withdrawal seizures
- Receiving or have received vagus nerve stimulation (VNS), electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or other somatic antidepressant treatments
- Currently taking or having taken within the 7 days before study entry any of the following exclusionary medications: antipsychotic medications, anticonvulsant medications, mood stabilizers, or central nervous system stimulants (antidepressant medication used for the treatment of depression or other purposes such as smoking cessation or pain are excluded since these agents may interfere with the testing of the major hypotheses under study)
- Uncontrolled narrow angle glaucoma
- Taking thyroid medication for hypothyroidism may be included only if stable on the medication for 3 months
- Using agents within the 7 days before study entry that are potential augmenting agents (e.g., T3 in the absence of thyroid disease, SAMe, St. John's Wort, lithium, buspirone)
- Therapy that is depression-specific
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
General Psychiatric Ambulatory Clinic
Ann Arbor, Michigan, 48105
UNC Chapel Hill Adult Diagnostic & Treatment Clinic
Chapel Hill, North Carolina, 27599-7160
Northwestern Psychiatric Outpatient Treatment Care Center
Chicago, Illinois, 60611
UT Southwestern Family Medicine Clinic
Dallas, Texas, 75390
Harbor UCLA Family Health Care Center
Harbor City, California, 90710
UCLA Internal Medicine Clinic
Los Angeles, California, 90024
Vine Hill Community Clinic
Nashville, Tennessee, 37212
Irving Goldman Primary Care at North Shore Hospital
New York, New York, 11040
Bellefield Clinic of WPIC
Pittsburgh, Pennsylvania, 15213
VCU Outpatient Psychiatry Clinic
Richmond, Virginia, 23298
MGH/Northshore Medical Center (Salem Psychiatric Facility)
Salem, Massachusetts, 01970
Veterans Affairs Medical Center/FIRM Primary Care Clinic
San Diego, California, 92161
Laureate Psychiatric Clinic and Hospital
Tulsa, Oklahoma, 74135
Tuscalossa VA Mental Health Clinic
Tuscaloosa, Alabama, 35404
Clinical Research Institute
Wichita, Kansas, 67214
About this study
This study will compare whether a combination of antidepressant medications is better than one antidepressant medication alone when given as initial treatment for people with chronic or recurrent major depressive disorder.
Read the detailed description
The overall aim of Combining Medications to Enhance Depression Outcomes (CO-MED) is to enhance remission rates for outpatients with chronic or recurrent nonpsychotic major depressive disorder (MDD) as defined by DSM-IV TR, treated in primary or psychiatric care settings.
Current evidence indicates that remission, the goal of treatment, is found in only about one-third of representative depressed outpatients treated for up to 14 weeks with an initial SSRI. In addition, even for those who do respond or remit, over one-third relapse in the subsequent 12 months. Combinations of antidepressants are used in practice at the second or subsequent steps when relapse occurs in the longer term, or, in some cases, even acutely as a first step when speed of effect is a clinical priority. Whether such combinations could potentially offer higher remission rates, lower attrition, or greater longer-term benefit if used as initial treatments as compared to monotherapy remains to be examined.
CO-MED will test whether two different medications when given in combination as the first treatment step, compared to one medication, will enhance remission rates, increase speed of remission, be tolerable, and provide better sustained benefits in the longer term. Results of this study will inform practitioners in managing the treatment of patients with chronic or recurrent MDD.
- Conditions
- Major Depressive Disorder
- Being tested
- SSRI + placebo, Escitalopram + Bupropion SR, Venlafaxine XR + Mirtazapine
- Keywords
- depression, medication, antidepressant, chronic, recurrent
- Medical subject headings
- Depressive Disorder, Major, Depression, Bronchiolitis Obliterans Syndrome, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSRI + placeboDrug
Also called escitalopram, placebo
Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
Escitalopram + Bupropion SRDrug
Also called escitalopram, bupropion-SR
Participant will take Burpopion SR (150 to 450 mg/day) + Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
Venlafaxine XR + MirtazapineDrug
Also called venlafaxine-XR, mirtazapine
Participants will take Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| SSRI + placebo | Active comparator | Participants will take escitalopram plus placebo. Receives: Drug: SSRI + placebo |
| Escitalopram + Bupropion SR | Active comparator | Participants will take escitalopram + bupropion-SR. Receives: Drug: Escitalopram + Bupropion SR |
| Venlafaxine XR + Mirtazapine | Active comparator | Participants will take venlafaxine-XR + mirtazapine. Receives: Drug: Venlafaxine XR + Mirtazapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptoms
Percentage of patients that achieve remission, as defined as QIDS total score below 6 for last 2 study visits. QIDS depression scores range from 0 (normal) to 27 (very severe).
Measured: Measured at Month 7
Secondary outcomes (1)
Quality of Life Inventory
The Quality of Life Inventory (QOLI) is a 32-item comprehensive self-report of satisfaction in 16 areas of life, such as love, work, and health. Each area is rated in terms of satisfaction and the relationship of that area to overall quality of life. It yields an overall raw score and satisfaction ratings for the 16 individual areas of life. The QOLI raw score is an average of weighted satisfaction ratings computed only over areas of life judged to be Important or Extremely Important to the respondent. Higher scores indicate higher reported quality of life.
Measured: Measured at Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionSep 2009
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 (20)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 665 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Madhukar H. Trivedi, MD, Principal investigator, University of Texas Southwestern Medical CenterStephen R. Wisniewski, PhD, Study director, University of PittsburghDiane Warden, PhD, MBA, Study director, University of Texas Southwestern Medical CenterKathy Shores-Wilson, PhD, Study director, University of Texas Southwestern Medical CenterDavid W. Morris, PhD, Study director, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590863
- Sponsor's protocol ID
- N01 MH090003-02
- Other IDs
- DSIR AT, N01MH090003
- Acronym
- CO-MED
- Status last verified
- Apr 2009
- First submitted
- 26 Dec 2007
- Last updated
- 23 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rush AJ, Trivedi MH, Stewart JW, Nierenberg AA, Fava M, Kurian BT, Warden D, Morris DW, Luther JF, Husain MM, Cook IA, Shelton RC, Lesser IM, Kornstein SG, Wisniewski SR. Combining medications to enhance depression outcomes (CO-MED): acute and long-term outcomes of a single-blind randomized study. Am J Psychiatry. 2011 Jul;168(7):689-701. doi: 10.1176/appi.ajp.2011.10111645. Epub 2011 May 2.
PubMed 21536692Olgiati P, Serretti A. Antidepressant emergent mood switch in major depressive disorder: onset, clinical correlates and impact on suicidality. Int Clin Psychopharmacol. 2023 Sep 1;38(5):342-351. doi: 10.1097/YIC.0000000000000479. Epub 2023 Jun 9.
PubMed 37351585Olgiati P, Fanelli G, Serretti A. Clinical correlates and prognostic implications of severe suicidal ideation in major depressive disorder. Int Clin Psychopharmacol. 2023 Jul 1;38(4):201-208. doi: 10.1097/YIC.0000000000000461. Epub 2023 Feb 27.
PubMed 36853754Olgiati P, Fanelli G, Atti AR, De Ronchi D, Serretti A. Clinical correlates and prognostic impact of binge-eating symptoms in major depressive disorder. Int Clin Psychopharmacol. 2022 Nov 1;37(6):247-254. doi: 10.1097/YIC.0000000000000422. Epub 2022 Jul 12.
PubMed 35815954Olgiati P, Serretti A. Persistence of suicidal ideation within acute phase treatment of major depressive disorder: analysis of clinical predictors. Int Clin Psychopharmacol. 2022 Sep 1;37(5):193-200. doi: 10.1097/YIC.0000000000000416. Epub 2022 Jul 7.
PubMed 35695646Olgiati P, Fanelli G, Serretti A. Obsessive-compulsive symptoms in major depressive disorder correlate with clinical severity and mixed features. Int Clin Psychopharmacol. 2022 Jul 1;37(4):166-172. doi: 10.1097/YIC.0000000000000396. Epub 2022 Feb 21.
PubMed 35191860Olgiati P, Serretti A. Post-traumatic stress disorder and childhood emotional abuse are markers of subthreshold bipolarity and worse treatment outcome in major depressive disorder. Int Clin Psychopharmacol. 2022 Jan 1;37(1):1-8. doi: 10.1097/YIC.0000000000000380.
PubMed 34686642Medeiros GC, Prueitt WL, Minhajuddin A, Patel SS, Czysz AH, Furman JL, Mason BL, Rush AJ, Jha MK, Trivedi MH. Childhood maltreatment and impact on clinical features of major depression in adults. Psychiatry Res. 2020 Nov;293:113412. doi: 10.1016/j.psychres.2020.113412. Epub 2020 Aug 18.
PubMed 32950785Jha MK, Minhajuddin A, South C, Rush AJ, Trivedi MH. Irritability and Its Clinical Utility in Major Depressive Disorder: Prediction of Individual-Level Acute-Phase Outcomes Using Early Changes in Irritability and Depression Severity. Am J Psychiatry. 2019 May 1;176(5):358-366. doi: 10.1176/appi.ajp.2018.18030355. Epub 2019 Mar 29.
PubMed 30922100Sies A, Demyttenaere K, Van Mechelen I. Studying treatment-effect heterogeneity in precision medicine through induced subgroups. J Biopharm Stat. 2019;29(3):491-507. doi: 10.1080/10543406.2019.1579220. Epub 2019 Feb 22.
PubMed 30794033De La Garza N, Rush AJ, Killian MO, Grannemann BD, Carmody TJ, Trivedi MH. The Concise Health Risk Tracking Self-Report (CHRT-SR) assessment of suicidality in depressed outpatients: A psychometric evaluation. Depress Anxiety. 2019 Apr;36(4):313-320. doi: 10.1002/da.22855. Epub 2018 Oct 29.
PubMed 30370613Gadad BS, Jha MK, Grannemann BD, Mayes TL, Trivedi MH. Proteomics profiling reveals inflammatory biomarkers of antidepressant treatment response: Findings from the CO-MED trial. J Psychiatr Res. 2017 Nov;94:1-6. doi: 10.1016/j.jpsychires.2017.05.012. Epub 2017 May 26.
PubMed 28628884Jha MK, Minhajuddin A, Gadad BS, Greer T, Grannemann B, Soyombo A, Mayes TL, Rush AJ, Trivedi MH. Can C-reactive protein inform antidepressant medication selection in depressed outpatients? Findings from the CO-MED trial. Psychoneuroendocrinology. 2017 Apr;78:105-113. doi: 10.1016/j.psyneuen.2017.01.023. Epub 2017 Jan 24.
PubMed 28187400Chekroud AM, Zotti RJ, Shehzad Z, Gueorguieva R, Johnson MK, Trivedi MH, Cannon TD, Krystal JH, Corlett PR. Cross-trial prediction of treatment outcome in depression: a machine learning approach. Lancet Psychiatry. 2016 Mar;3(3):243-50. doi: 10.1016/S2215-0366(15)00471-X. Epub 2016 Jan 21.
PubMed 26803397Warden D, Trivedi MH, Carmody T, Toups M, Zisook S, Lesser I, Myers A, Kurian KR, Morris D, Rush AJ. Adherence to antidepressant combinations and monotherapy for major depressive disorder: a CO-MED report of measurement-based care. J Psychiatr Pract. 2014 Mar;20(2):118-32. doi: 10.1097/01.pra.0000445246.46424.fe.
PubMed 24638046
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Medications to Enhance Depression Outcomes
- ClinicalTrials.gov ID
- NCT00590863
- Acronym / sponsor ID
- CO-MED / N01 MH090003-02
- Conditions
- Major Depressive Disorder
- Keywords
- depression, medication, antidepressant, chronic, recurrent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 665 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 23 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare whether a combination of antidepressant medications is better than one antidepressant medication alone when given as initial treatment for people with chronic or recurrent major depressive disorder.
Detailed description
The overall aim of Combining Medications to Enhance Depression Outcomes (CO-MED) is to enhance remission rates for outpatients with chronic or recurrent nonpsychotic major depressive disorder (MDD) as defined by DSM-IV TR, treated in primary or psychiatric care settings.
Current evidence indicates that remission, the goal of treatment, is found in only about one-third of representative depressed outpatients treated for up to 14 weeks with an initial SSRI. In addition, even for those who do respond or remit, over one-third relapse in the subsequent 12 months. Combinations of antidepressants are used in practice at the second or subsequent steps when relapse occurs in the longer term, or, in some cases, even acutely as a first step when speed of effect is a clinical priority. Whether such combinations could potentially offer higher remission rates, lower attrition, or greater longer-term benefit if used as initial treatments as compared to monotherapy remains to be examined.
CO-MED will test whether two different medications when given in combination as the first treatment step, compared to one medication, will enhance remission rates, increase speed of remission, be tolerable, and provide better sustained benefits in the longer term. Results of this study will inform practitioners in managing the treatment of patients with chronic or recurrent MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SSRI + placebo | Active comparator | Drug: SSRI + placeboParticipants will take escitalopram plus placebo. |
| Escitalopram + Bupropion SR | Active comparator | Drug: Escitalopram + Bupropion SRParticipants will take escitalopram + bupropion-SR. |
| Venlafaxine XR + Mirtazapine | Active comparator | Drug: Venlafaxine XR + MirtazapineParticipants will take venlafaxine-XR + mirtazapine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Seeking treatment at the primary or specialty care site, and be planning to continue living in the area of that clinic for the duration of the study
- Meets clinical criteria for nonpsychotic MDD, recurrent (with the current episode being at least 2 months in duration), or chronic (current episode greater than 2 years) as defined by a clinical interview and confirmed by the MINI International Neuropsychiatric Interview (MINI)
- Screening 17 item HRSD score of 16 or greater
- Treatment with antidepressant medication combinations is clinically acceptable
- Patient with and without current suicidal ideation may be included in the study as long as outpatient treatment is clinically appropriate
Key exclusion criteria (24 listed)
- Pregnant or breastfeeding
- Plans to become pregnant over the ensuing 8 months following study entry or are sexually active and not using adequate birth control
- History (lifetime) of psychotic depression, schizophrenia, bipolar (I, II, or NOS), schizoaffective, or other Axis I psychotic disorders
- Current psychotic symptom(s)
- History (within the last 2 years before study entry) of anorexia or bulimia
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 |
|---|---|---|
| SSRI + placeboAlso: escitalopram, placeboParticipants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit. | Drug | SSRI + placebo |
| Escitalopram + Bupropion SRAlso: escitalopram, bupropion-SRParticipant will take Burpopion SR (150 to 450 mg/day) + Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit. | Drug | Escitalopram + Bupropion SR |
| Venlafaxine XR + MirtazapineAlso: venlafaxine-XR, mirtazapineParticipants will take Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit. | Drug | Venlafaxine XR + Mirtazapine |
Primary outcome
Quick Inventory of Depressive Symptoms
Time frame: Measured at Month 7
Percentage of patients that achieve remission, as defined as QIDS total score below 6 for last 2 study visits. QIDS depression scores range from 0 (normal) to 27 (very severe).
1 secondary outcome
Quality of Life Inventory
Time frame: Measured at Month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21536692Rush AJ, Trivedi MH, Stewart JW, Nierenberg AA, Fava M, Kurian BT, Warden D, Morris DW, Luther JF, Husain MM, Cook IA, Shelton RC, Lesser IM, Kornstein SG, Wisniewski SR. Combining medications to enhance depression outcomes (CO-MED): acute and long-term outcomes of a single-blind randomized study. Am J Psychiatry. 2011 Jul;168(7):689-701. doi: 10.1176/appi.ajp.2011.10111645. Epub 2011 May 2.
- Derived from this study: PubMed 37351585Olgiati P, Serretti A. Antidepressant emergent mood switch in major depressive disorder: onset, clinical correlates and impact on suicidality. Int Clin Psychopharmacol. 2023 Sep 1;38(5):342-351. doi: 10.1097/YIC.0000000000000479. Epub 2023 Jun 9.
- Derived from this study: PubMed 36853754Olgiati P, Fanelli G, Serretti A. Clinical correlates and prognostic implications of severe suicidal ideation in major depressive disorder. Int Clin Psychopharmacol. 2023 Jul 1;38(4):201-208. doi: 10.1097/YIC.0000000000000461. Epub 2023 Feb 27.
- Derived from this study: PubMed 35815954Olgiati P, Fanelli G, Atti AR, De Ronchi D, Serretti A. Clinical correlates and prognostic impact of binge-eating symptoms in major depressive disorder. Int Clin Psychopharmacol. 2022 Nov 1;37(6):247-254. doi: 10.1097/YIC.0000000000000422. Epub 2022 Jul 12.
- Derived from this study: PubMed 35695646Olgiati P, Serretti A. Persistence of suicidal ideation within acute phase treatment of major depressive disorder: analysis of clinical predictors. Int Clin Psychopharmacol. 2022 Sep 1;37(5):193-200. doi: 10.1097/YIC.0000000000000416. Epub 2022 Jul 7.
- Derived from this study: PubMed 35191860Olgiati P, Fanelli G, Serretti A. Obsessive-compulsive symptoms in major depressive disorder correlate with clinical severity and mixed features. Int Clin Psychopharmacol. 2022 Jul 1;37(4):166-172. doi: 10.1097/YIC.0000000000000396. Epub 2022 Feb 21.
- Derived from this study: PubMed 34686642Olgiati P, Serretti A. Post-traumatic stress disorder and childhood emotional abuse are markers of subthreshold bipolarity and worse treatment outcome in major depressive disorder. Int Clin Psychopharmacol. 2022 Jan 1;37(1):1-8. doi: 10.1097/YIC.0000000000000380.
- Derived from this study: PubMed 32950785Medeiros GC, Prueitt WL, Minhajuddin A, Patel SS, Czysz AH, Furman JL, Mason BL, Rush AJ, Jha MK, Trivedi MH. Childhood maltreatment and impact on clinical features of major depression in adults. Psychiatry Res. 2020 Nov;293:113412. doi: 10.1016/j.psychres.2020.113412. Epub 2020 Aug 18.
- Derived from this study: PubMed 30922100Jha MK, Minhajuddin A, South C, Rush AJ, Trivedi MH. Irritability and Its Clinical Utility in Major Depressive Disorder: Prediction of Individual-Level Acute-Phase Outcomes Using Early Changes in Irritability and Depression Severity. Am J Psychiatry. 2019 May 1;176(5):358-366. doi: 10.1176/appi.ajp.2018.18030355. Epub 2019 Mar 29.
- Derived from this study: PubMed 30794033Sies A, Demyttenaere K, Van Mechelen I. Studying treatment-effect heterogeneity in precision medicine through induced subgroups. J Biopharm Stat. 2019;29(3):491-507. doi: 10.1080/10543406.2019.1579220. Epub 2019 Feb 22.
- Derived from this study: PubMed 30370613De La Garza N, Rush AJ, Killian MO, Grannemann BD, Carmody TJ, Trivedi MH. The Concise Health Risk Tracking Self-Report (CHRT-SR) assessment of suicidality in depressed outpatients: A psychometric evaluation. Depress Anxiety. 2019 Apr;36(4):313-320. doi: 10.1002/da.22855. Epub 2018 Oct 29.
- Derived from this study: PubMed 28628884Gadad BS, Jha MK, Grannemann BD, Mayes TL, Trivedi MH. Proteomics profiling reveals inflammatory biomarkers of antidepressant treatment response: Findings from the CO-MED trial. J Psychiatr Res. 2017 Nov;94:1-6. doi: 10.1016/j.jpsychires.2017.05.012. Epub 2017 May 26.
Related trials for Major Depressive Disorder
RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
Recruiting
EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Depressive Disorder, Major
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
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.
Madhukar H. Trivedi, MD principal investigator
University of Texas Southwestern Medical Center
Stephen R. Wisniewski, PhD study director
University of Pittsburgh
Diane Warden, PhD, MBA study director
University of Texas Southwestern Medical Center
15 sites 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 SR and Venlafaxine XR + Mirtazapine in people with Major Depressive Disorder, run by National Institute of Mental Health (NIMH) at 15 sites 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 5 inclusion and 24 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 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Yes. Results are posted in the registry (first posted 23 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quick Inventory of Depressive Symptoms (time frame: Measured at Month 7). 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 NCT00590863, which also lists 20 linked publications.
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 23 Apr 2014.