Trial record 1 of 2 for:    CO-MED NIMH
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Combining Medications to Enhance Depression Outcomes (CO-MED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00590863
First received: December 26, 2007
Last updated: April 21, 2014
Last verified: April 2009

December 26, 2007
April 21, 2014
March 2008
September 2009   (final data collection date for primary outcome measure)
Quick Inventory of Depressive Symptoms [ Time Frame: Measured at Month 7 ] [ Designated as safety issue: No ]
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).
Remission rates in patients with chronic and/or recurrent major depression. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00590863 on ClinicalTrials.gov Archive Site
Quality of Life Inventory [ Time Frame: Measured at Month 7 ] [ Designated as safety issue: No ]
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.
anxiety, social functioning, quality of life, cognitive and physical well being, treatment emergent psychiatric symptoms, side-effect burden [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Combining Medications to Enhance Depression Outcomes
Combining Medications to Enhance Depression Outcomes

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: SSRI + 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.
    Other Names:
    • escitalopram
    • placebo
  • Drug: 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.
    Other Names:
    • escitalopram
    • bupropion-SR
  • Drug: 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.
    Other Names:
    • venlafaxine-XR
    • mirtazapine
  • Active Comparator: SSRI + placebo
    Participants will take escitalopram plus placebo.
    Intervention: Drug: SSRI + placebo
  • Active Comparator: Escitalopram + Bupropion SR
    Participants will take escitalopram + bupropion-SR.
    Intervention: Drug: Escitalopram + Bupropion SR
  • Active Comparator: Venlafaxine XR + Mirtazapine
    Participants will take venlafaxine-XR + mirtazapine.
    Intervention: Drug: Venlafaxine XR + Mirtazapine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
665
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00590863
N01 MH090003-02, DSIR AT
Yes
National Institute of Mental Health (NIMH)
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Madhukar H. Trivedi, MD University of Texas Southwestern Medical Center
Study Director: Stephen R. Wisniewski, PhD University of Pittsburgh
Study Director: Diane Warden, PhD, MBA University of Texas Southwestern Medical Center
Study Director: Kathy Shores-Wilson, PhD University of Texas Southwestern Medical Center
Study Director: David W. Morris, PhD University of Texas Southwestern Medical Center
National Institute of Mental Health (NIMH)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP