Phase 4
Completed N=151
Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease
Major Depressive Disorder · Idiopathic Parkinson Disease
Source: ClinicalTrials.gov NCT00437125 ↗
Enrolled (actual)
151
Serious AEs
2.0%
Results posted
Aug 2010
Primary outcomePrimary: Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death — 13 participants
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.
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 | — |
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. Informational only — not medical advice.