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Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD
Phase 3 trial testing Levomilnacipran in Major Depressive Disorder in 60 participants. Completed in 12 June 2018.
| Lead sponsor | Duke University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 23 January 2017 |
| Primary completion | 12 June 2018 |
| Estimated completion | 12 June 2018 |
| Sites | 1 location across United States |
Duke University
Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Total scores will range from 0 to 60. Higher scores indicate greater severity of depressive episodes.
| Group | Value | 95% CI |
|---|---|---|
| Levomilnacipran | -5.81 | ± 6.080 |
| Quetiapine | -6.97 | ± 7.632 |
Remission was defined as \[\>or=50% reduction in MADRS score with MADRS \<or=10\] and response was defined as \[\>or=50% reduction in MADRS with MADRS \>10\]. Response rate included remission and response.
| Group | Value | 95% CI |
|---|---|---|
| Levomilnacipran | 3 | |
| Quetiapine | 7 |
Remission was defined as \[\>or=50% reduction in MADRS score with MADRS \<or=10\]
| Group | Value | 95% CI |
|---|---|---|
| Levomilnacipran | 2 | |
| Quetiapine | 3 |
Number of words correctly recalled by the respondent is recorded. 1 point for each word correctly recalled. Total score range of 0-40. Higher scores mean better cognitive function.
| Group | Value | 95% CI |
|---|---|---|
| Levomilnacipran | 2.28 | ± 5.694 |
| Quetiapine | 2.90 | ± 5.255 |
DSST measures working memory and visuospatial processing. 1 point for each object correctly substituted from number to each matched symbol. Total score range of 0-89. Higher scores mean better cognitive function.
| Group | Value | 95% CI |
|---|---|---|
| Levomilnacipran | 3.21 | ± 9.321 |
| Quetiapine | 0.87 | ± 7.431 |
CGI-S is a 7 point scale that assess the severity of illness and requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is used to assess the clinician's view of the patient's global functioning. Total score range of 0-7.
| Group | Value | 95% CI |
|---|---|---|
| Levomilnacipran | 13 | |
| Quetiapine | 13 |
CGI-I a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is used to assess the clinician's view of the patient's global functioning. Total score range of 0-7.
| Group | Value | 95% CI |
|---|---|---|
| Levomilnacipran | 21 | |
| Quetiapine | 24 |
A questionnaire used by clinicians to rate the severity of a patient's anxiety. Total score range of 0-48. A higher score indicates greater anxiety.
| Group | Value | 95% CI |
|---|---|---|
| Levomilnacipran | -3.89 | ± 4.969 |
| Quetiapine | -5.53 | ± 5.859 |
A self-reported brief scale to assess impairment of work/school, social life and family and home. Total score range of 0-30. A higher score indicates greater impairment.
| Group | Value | 95% CI |
|---|---|---|
| Levomilnacipran | -3.79 | ± 6.477 |
| Quetiapine | -0.10 | ± 8.126 |
Self-Administered assessment measuring lack of motivation not attributable to diminished level of consciousness, cognitive impairment, or emotional distress. Total scores range from 0-54. Higher scores indicate greater apathy.
| Group | Value | 95% CI |
|---|---|---|
| Levomilnacipran | -2.07 | ± 8.689 |
| Quetiapine | -1.83 | ± 7.852 |
ASEX is scale for sexual dysfunction to assess safety and tolerability of medication. Total scores range from 5-30. Higher scores indicate greater sexual dysfunction.
| Group | Value | 95% CI |
|---|---|---|
| Levomilnacipran | -0.76 | ± 2.923 |
| Quetiapine | -0.30 | ± 4.829 |
Time frame: Screening to Week 9. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Levomilnacipran | Quetiapine |
|---|---|---|---|
| Drowsiness | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Increase Appetite | General disorders | — | — |
| Weight Gain | General disorders | — | — |
| Sweating | General disorders | — | — |
| Confusion | Nervous system disorders | — | — |
| Dysuria | Renal and urinary disorders | — | — |
| Weight Loss | General disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Dry Mouth | General disorders | — | — |
Data from ClinicalTrials.gov NCT02720198 adverse events section.
This study's primary objective is to compare the efficacy and tolerability of switching patients with inadequate relief on generic SSRIs to levomilnacipran versus adding a new treatment (quetiapine) to the participants' existing treatment with people diagnosed with depression (major depression disorder). The secondary objective is to examine the response and remission rates following the switch from a generic SSRI to levomilnacipran ER and augmentation with quetiapine along with examining changes in neurocognitive and apathy measures after the switch.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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