Phase 4
Completed N=245
Does Dual Therapy Hasten Antidepressant Response?
Source: ClinicalTrials.gov NCT00519428 ↗Enrolled (actual)
245
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7 — 8; 9; 10 weeks — p=.05
◆ Published Evidence
Established
78citations · ~7 / year
Treatment of maternal depression in a medication clinical trial and its effect on children.
Summary
This study will utilize a randomized double-blind design to evaluate whether initial treatment with two anti-depressant medications (escitalopram and bupropion) results in more rapid remission and greater over-all remission rates than either monotherapy in 240 depressed subjects.
Linked Publications (4)
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Treatment of maternal depression in a medication clinical trial and its effect on children.
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Combination antidepressant therapy for major depressive disorder: speed and probability of remission.
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Does negative affectivity predict differential response to an SSRI versus a non-SSRI antidepressant?
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One size does not fit all: notable individual variation in brain activity correlates of antidepressant treatment response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7 |
8; 9; 10 | .05 |
| SECONDARY Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12 |
52; 46; 34 | — |
| SECONDARY Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17) |
10; 9; 12 | .0916 |
| SECONDARY Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score |
2.65; 2.63; 2.74 | — |
| SECONDARY Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF) |
3.0; 3.0; 3.1 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women ages 18-65
- Major Depressive Disorder as primary diagnosis
- Physically healthy
- Signs informed consent
- Montgomery Asberg Depression Rating Scale (MADRS) >= 22
Exclusion Criteria
- Bipolar Disorder (ie, Bipolar I, Bipolar II, Bipolar NOS)
- Life-time history of psychosis
- Current (ie, last 6 months) drug or alcohol abuse or dependence (except nicotine)
- Currently taking effective antidepressant medication
- Prior adequate treatment in current depressive episode with a selective serotonin re-uptake inhibitor (SSRI), bupropion (BUP) or bupropion (BUP) + a selective serotonin re-uptake inhibitor (SSRI) ("adequate" is defined as >= 4 weeks taking >= 2/3 Physician's Desk Reference (PDR) maximal dose
- Most recent antidepressant was within 5 weeks for fluoxetine and 1 week for all others
- Currently taking a medication contraindicated with either study medication
- Life time history of anorexia or bulimia
- Life time history of seizure or known increased seizure risk (e.g., history of significant brain trauma, taking pro-convulsant medication, known anatomical brain lesion)
- Currently taking psychoactive medication deemed to be necessary (including but not limited anticonvulsants, antidepressants, antipsychotics, steroids, and B-blockers); occasional use of hypnotics (ie, less than three times per week) will be allowed
- Unstable medical condition (ie, condition not adequately stabilized for >= 3 months)
- Prior intolerance to escitalopram (ESC) or bupropion (BUP)
- Inadequate understanding of English (for US site; Canadian site permits French fluency)
- Currently pregnant or breast-feeding; fecund women not using adequate contraceptive methods
Data sourced from ClinicalTrials.gov (NCT00519428) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.