A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

Browse trials for

• Depressive Disorder 4,845
• Depressive Disorder, Major 2,741

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 339 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Study arms

• Experimental
  Duloxetine Hydrochloride (60 mg)

  Up to Week 4: 60 milligrams (mg) every morning and placebo every evening, by mouth (PO). Week 4 to Week 8: Responders continued on same dose as before; Nonresponders received 60 mg every morning and 60 mg every evening added to the placebo

  Drug: Duloxetine hydrochloride · Drug: Placebo

• Experimental
  Duloxetine Hydrochloride (120 mg)

  Up to Week 4: 60 mg every morning and 60 mg every evening, PO. Week 4 to Week 8: Responders continued on same dose as before; Nonresponders continued as before with a placebo capsule added to the evening dose

  Drug: Duloxetine hydrochloride · Drug: Placebo

Interventions

• DrugDuloxetine hydrochloride

  60 mg once or twice a day, by mouth

  Also known as: LY248686, Cymbalta

• DrugPlacebo

  placebo capsule by mouth

Primary outcomes

1. Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

   Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

   Time frame: Baseline to Week 4

Secondary outcomes

1. Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline

   The HAMD-6 (Items 1,2,7,8,10,13 from the 17-item HAMD) evaluates "core" symptoms of Major Depressive Disorder (MDD). Total scores range from 0 (normal) to 22 (severe).

   Time frame: Baseline to Weeks 1, 2, 3, 4, 6, 8

2. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline

   Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

   Time frame: Baseline to Weeks 1, 2, 3, 4, 6, 8

3. Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6)

   Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and 6-Item Hamilton Depression Scale (HAMD-6) total scores were evaluated following dose up-titration in those patients who did not achieve the minimum 50% response for primary endpoint. MADRS is a rating scale for severity of depressive mood symptoms. Total scores range from 0 (low severity of symptoms) to 60 (high severity of symptoms). The HAMD-6, derived by the sum of HAMD-17 items 1, 2, 7, 8, 10 and 13, evaluates "core" symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe).

   Time frame: 4 to 8 weeks

4. Clinical Global Impression of Severity (CGI-S) Scores at Each Visit

   Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

   Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8

5. Clinical Global Impression of Improvement (CGI-I) at Each Visit

   Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).

   Time frame: Weeks 1, 2, 3, 4, 6, 8

6. Patient Global Impression of Improvement (PGI-I) Score at Each Visit

   A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

   Time frame: Weeks 1, 2, 3, 4, 6, 8

7. Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8

   The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.

   Time frame: Baseline and Weeks 4 and 8

8. Percentage of Responders

   Patients with reduction in MADRS score ≥50% after 4 weeks were to stay on previous dose of duloxetine. Those with reduction in MADRS \<50% were to receive 120 mg for remaining 4 weeks of treatment (up-titration from 60 mg to 120 mg for those randomized to 60 mg, and addition of placebo to 120 mg dose for those randomized to 120 mg). However, 2/70 patients randomized to 60 mg and then up-titrated to 120 mg after 4 weeks had reduction in MADRS ≥50% after 4 weeks, and 3/64 patients randomized to 120 mg and then given placebo in addition after 4 weeks had reduction in MADRS ≥50% after 4 weeks.

   Time frame: 4 to 8 weeks

9. Patients Reaching Remission

   Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8.

   Time frame: Week 8

10. Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8

    The RFL questionnaire is an instrument that evaluates patient's reasons for not committing suicide using a 6-point rating scale, where 1 is "not at all important" and 6 is "extremely important". The questionnaire required participants to rate how important each item would be for living, if suicide was contemplated. Mean scores could range from 0 to 6.

    Time frame: Baseline and Week 8

11. Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication

    Number of participants using medication for anxiety and sleep disturbances.

    Time frame: over 8 weeks

12. Number of Patients With Potentially Clinically Significant Laboratory Findings

    Laboratory results that were potentially clinically significant.

    Time frame: over 8 weeks

13. Discontinuations Due to Adverse Events (AE)

    Listing of adverse events (AE) that led to treatment discontinuation (DC).

    Time frame: over 8 weeks

14. Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study

    Systolic and diastolic blood pressure and pulse rate were measured after 2 minutes rest in a supine position. High values were: diastolic blood pressure ≥90 mm Hg and increase from baseline of ≥10 mm Hg; systolic blood pressure ≥140 mm Hg and increase from baseline of ≥10 mm Hg; pulse rate ≥100 beats per minute (bpm) and an increase of ≥10 bpm from baseline.

    Time frame: over 8 weeks

15. Change From Baseline to Week 4 and Week 8 in Weight

    Change in weight = Post-baseline visit minus baseline.

    Time frame: Baseline to Weeks 4 and 8

Baseline characteristics

6 further baseline measures are reported on the registry.

Publications

• Brecht S, Desaiah D, Marechal ES, Santini AM, Podhorna J, Guelfi JD. Efficacy and safety of duloxetine 60 mg and 120 mg daily in patients hospitalized for severe depression: a double-blind randomized trial. J Clin Psychiatry. 2011 Aug;72(8):1086-94. doi: 10.4088/JCP.09m05723blu. Epub 2010 Sep 21. PubMed 20868642 ↗
• Demyttenaere K, Desaiah D, Raskin J, Cairns V, Brecht S. Suicidal thoughts and reasons for living in hospitalized patients with severe depression: post-hoc analyses of a double-blind randomized trial of duloxetine. Prim Care Companion CNS Disord. 2014;16(3):PCC.13m01591. doi: 10.4088/PCC.13m01591. Epub 2014 May 1. PubMed 25317365 ↗