Phase 4
N=151
Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease
Major Depressive Disorder · Idiopathic Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT00437125 ↗Enrolled (actual)
151
Serious AEs
2.0%
Results posted
Aug 2010
Primary outcome: Primary: Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death — 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Duloxetine hydrochloride (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death |
13 | — |
| SECONDARY Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score |
32.0; -0.3 | 0.5553 |
| SECONDARY Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale |
6.8; -3.5; 4.2; -1.2; 1.9; -0.6 | <0.0001 sig |
| SECONDARY Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI) |
8.6; -2.8; -3.3; -3.2 | <0.0001 sig |
| SECONDARY Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score |
19.2; -10.1 | <0.0001 sig |
| SECONDARY Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale |
4.0; -1.5 | <0.0001 sig |
| SECONDARY Patient's Global Impression-Improvement at Week 12 |
5; 63; 38; 10; 3; 0 | — |
| SECONDARY Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score |
21.6; -12.0 | <0.0001 sig |
| SECONDARY Change From Baseline to 12 Weeks in Visual Analog Scale (VAS) |
30.5; -5.1; 15.9; -5.4; 34.9; -10.2 | 0.0027 sig |
| SECONDARY Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score |
32.9; -7.7 | <0.0001 sig |
| SECONDARY Average Change From Baseline to 12 Weeks in Blood Pressure |
-0.17; 0.12; -0.30; -0.45 | — |
| SECONDARY Average Change From Baseline to 12 Weeks in Heart Rate |
1.61; 1.16 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study |
3 | — |
| SECONDARY Laboratory Analytes |
— | — |
| SECONDARY Number of Participants Who Responded to Treatment by 12 Weeks |
90 | — |
| SECONDARY Number of Participants Who Reached Remission by 12 Weeks |
68 | — |
Summary
This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label fashion, in depressed patients with Parkinson's disease during 12 weeks treatment.
Eligibility Criteria
Inclusion Criteria
- Are outpatients, male or female, 30 through 75 years of age
- Meet diagnostic criteria for major depression episode and a clinical diagnosis of idiopathic Parkinson's disease
- Have a clinician-rated 17-item Hamilton Depression Rating Scale (HAMD17) total score greater than or equal to 15, a Beck Depression Inventory (BDI) total score greater than or equal to 13 and a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 3 at both Visit 1 and Visit 2
- Have satisfactory cognitive function
- Have been held on stable dosage of antiparkinsonian medications for at least 4 weeks immediately prior to Visit 1
Exclusion Criteria
- Any current primary psychiatric diagnosis other than Major depressive episode, and any personality disorder that could interfere with the compliance with the study protocol
- Atypical or secondary parkinsonism due to drugs or diseases with features of Parkinson's disease
- Motor conditions for which it is to be expected to change the antiparkinsonian treatment during the course of the study
- Clinically significant laboratory abnormalities or serious, unstable medical illness
- Lack of response of current episode to two or more adequate courses of antidepressant therapy
Data sourced from ClinicalTrials.gov (NCT00437125). 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.