A Phase 4 interventional study of Duloxetine hydrochloride in Major Depressive Disorder and Idiopathic Parkinson Disease, sponsored by Eli Lilly and Company. Completed at 13 sites in Italy. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-09-08.
Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 151 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Drug: Duloxetine hydrochloride
Duloxetine 30 milligram (mg) once daily (QD) orally (PO) for 1 week, then duloxetine 60 mg QD PO for 11 weeks
Also known as: LY248686; Cymbalta
Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death
The results reported are the number of participants who discontinued the study as a result of an adverse event (serious or other) or death.
Time frame: baseline through 12 weeks
Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Rating tool to follow the longitudinal course of Parkinson's Disease. It is composed of Section I: Mentation, Behavior, and Mood; Section II: Activities of Daily Living; Section III: Motor Examination; Section IV: Complications of therapy. These are evaluated by interview. Some sections require that multiple grades be assigned to each extremity. Only Sections II and III were rated in this study. A total of 160 points are possible (52 in Section II and 108 in Section III), where 0 represents no disability and 160 indicates maximal grade of disability.
Time frame: baseline, 12 weeks
Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale
Clinician-rated scale, providing side effect ratings of psychopharmacological medications. 48 items, each item is rated on a 4-point scale (0=not present; 1=mild; 2=moderate; 3=severe). The test is divided in 6 subscales, total scores for each subscale are calculated based on a weighted secondary scoring system. Subscales: psychic (score range:0-30), neurological (score range:0-24), autonomic (score range:0-33), other (score range:0-75), global assesment by subject (score range:0-3), and global assessment by doctor (score range:0-3). Higher ratings indicate greater impairment.
Time frame: baseline, 12 weeks
Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)
Self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. 19 individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The subject self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The total score is the sum of the 7 component scores (total score range: 0-21).
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time frame: baseline, 12 weeks
Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale
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, 12 weeks
Patient's Global Impression-Improvement at Week 12
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. Scoring: 1=very much better; 2=much better; 3=low better; 4=no change; 5=low worse; 6=much worse; 7=very much worse.
Time frame: 12 weeks
Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time frame: baseline, 12 weeks
Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). Here, the line was only 93 mm long due to an error on the clinical research form and scores were adjusted to 0 to 93.
Time frame: baseline, 12 weeks
Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score
The PDQ-39 has 39 items. Higher scores reflect lower quality of life. The PDQ-39 has eight subscales: mobility (10 items), activities of daily living (six items), emotional wellbeing (six items), stigma (four items), social support (three items), cognition (four items), communication (three items), and bodily discomfort (three items). Items in each subscale, as well in the total scale, can be summarized into an index and transformed linearly to a 0-100 scale.
Time frame: baseline, 12 weeks
Average Change From Baseline to 12 Weeks in Blood Pressure
For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.
Time frame: baseline through 12 weeks
Average Change From Baseline to 12 Weeks in Heart Rate
For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.
Time frame: baseline through 12 weeks
Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study
Included were participants with normal ECG at baseline who developed abnormal ECGs during the study.
Time frame: baseline through 12 weeks
Laboratory Analytes
Laboratory analytes were collected to assess adverse events which are listed in the reported adverse events section.
Time frame: baseline through 12 weeks
Number of Participants Who Responded to Treatment by 12 Weeks
Response was defined as a \>= 50% reduction in 17-item Hamilton Depression rating scale (HAMD) scores. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time frame: 12 weeks
Number of Participants Who Reached Remission by 12 Weeks
Remission was defined as reaching a 17-item Hamilton Depression Rating Scale (HAMD) total score \<=7. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time frame: 12 weeks
| Milestone | Duloxetine |
|---|---|
| Started | 151 |
| Completed | 119 |
| Not completed | 32 |
| Withdrew: Adverse event | 12 |
| Withdrew: Death | 1 |
| Withdrew: Clinical relapse | 1 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 13 |
| Withdrew: Withdrawal by caregiver | 2 |
| Withdrew: Physician decision | 1 |
The results reported are the number of participants who discontinued the study as a result of an adverse event (serious or other) or death.
| participants | Duloxetine |
|---|---|
| Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death | 13 |
Rating tool to follow the longitudinal course of Parkinson's Disease. It is composed of Section I: Mentation, Behavior, and Mood; Section II: Activities of Daily Living; Section III: Motor Examination; Section IV: Complications of therapy. These are evaluated by interview. Some sections require that multiple grades be assigned to each extremity. Only Sections II and III were rated in this study. A total of 160 points are possible (52 in Section II and 108 in Section III), where 0 represents no disability and 160 indicates maximal grade of disability.
| units on a scale | Duloxetine |
|---|---|
| baseline; n=151 | 32.0 ± 12.6 |
| change; n=149 | -0.3 ± 6.1 |
Clinician-rated scale, providing side effect ratings of psychopharmacological medications. 48 items, each item is rated on a 4-point scale (0=not present; 1=mild; 2=moderate; 3=severe). The test is divided in 6 subscales, total scores for each subscale are calculated based on a weighted secondary scoring system. Subscales: psychic (score range:0-30), neurological (score range:0-24), autonomic (score range:0-33), other (score range:0-75), global assesment by subject (score range:0-3), and global assessment by doctor (score range:0-3). Higher ratings indicate greater impairment.
| units on a scale | Duloxetine |
|---|---|
| Psychic subscale, baseline; n=136 | 6.8 ± 4.6 |
| Psychic subscale, change; n=114 | -3.5 ± 4.4 |
| Neurological subscale, baseline; n=132 | 4.2 ± 2.8 |
| Neurological subscale, change; n=112 | -1.2 ± 1.9 |
| Autonomic subscale, baseline; n=132 | 1.9 ± 2.2 |
| Autonomic subscale, change; n=113 | -0.6 ± 1.9 |
| Other subscale, baseline; n=49 | 0.9 ± 2.3 |
| Other subscale, baseline; n=35 | 0.2 ± 2.3 |
| Global assessment by participant, baseline; n=150 | 0.2 ± 0.5 |
| Global assessment by participant, change; n=129 | 0.1 ± 0.7 |
| Global assessment by doctor, baseline; n=150 | 0.1 ± 0.5 |
| Global assessment by doctor, change; n=129 | 0.1 ± 0.7 |
Self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. 19 individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The subject self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The total score is the sum of the 7 component scores (total score range: 0-21).
| units on a scale | Duloxetine |
|---|---|
| baseline, n=147 | 8.6 ± 3.7 |
| 4 weeks change, n=134 | -2.8 ± 3.1 |
| 8 weeks change, n=134 | -3.3 ± 3.5 |
| 12 weeks change, n=134 | -3.2 ± 3.5 |
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
| units on a scale | Duloxetine |
|---|---|
| baseline | 19.2 ± 3.5 |
| change | -10.1 ± 6.5 |
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).
| units on a scale | Duloxetine |
|---|---|
| baseline | 4.0 ± 0.7 |
| change | -1.5 ± 1.3 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. Scoring: 1=very much better; 2=much better; 3=low better; 4=no change; 5=low worse; 6=much worse; 7=very much worse.
| participants | Duloxetine |
|---|---|
| score=1 | 5 |
| score=2 | 63 |
| score=3 | 38 |
| score=4 | 10 |
| score=5 | 3 |
| score=6 | 0 |
| score=7 | 0 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
| units on a scale | Duloxetine |
|---|---|
| baseline, n=149 | 21.6 ± 6.1 |
| change, n=122 | -12.0 ± 7.8 |
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). Here, the line was only 93 mm long due to an error on the clinical research form and scores were adjusted to 0 to 93.
| units on a scale | Duloxetine |
|---|---|
| Overall pain, baseline; n=147 | 30.5 ± 24.1 |
| Overall pain, change; n=146 | -5.1 ± 20.1 |
| Headaches, baseline; n=147 | 15.9 ± 20.3 |
| Headaches, change; n=146 | -5.4 ± 17.1 |
| Back ache, baseline; n=147 | 34.9 ± 27.2 |
| Back ache, change; n=146 | -10.2 ± 20.8 |
| Shoulder pain, baseline; n=147 | 26.7 ± 27.1 |
| Shoulder pain, change; n=146 | -10.3 ± 22.1 |
| Interference, baseline; n=147 | 30.4 ± 26.8 |
| Interference, change; n=146 | -8.2 ± 22.3 |
| Pain while awake, baseline; n=147 | 31.7 ± 25.9 |
| Pain while awake, change; n=146 | -9.9 ± 21.8 |
The PDQ-39 has 39 items. Higher scores reflect lower quality of life. The PDQ-39 has eight subscales: mobility (10 items), activities of daily living (six items), emotional wellbeing (six items), stigma (four items), social support (three items), cognition (four items), communication (three items), and bodily discomfort (three items). Items in each subscale, as well in the total scale, can be summarized into an index and transformed linearly to a 0-100 scale.
| units on a scale | Duloxetine |
|---|---|
| baseline; n=147 | 32.9 ± 12.5 |
| change; n=118 | -7.7 ± 9.9 |
For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.
| millimeter mercury | Duloxetine |
|---|---|
| systolic blood pressure, standing; n=146 | -0.17 ± 8.03 |
| diastolic blood pressure, standing; n=146 | 0.12 ± 6.16 |
| systolic blood pressure, supine; n=145 | -0.30 ± 8.71 |
| diastolic blood pressure, supine; n=145 | -0.45 ± 6.29 |
For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.
| beats per minute | Duloxetine |
|---|---|
| standing, n=145 | 1.61 ± 7.7 |
| supine, n=145 | 1.16 ± 7.9 |
Included were participants with normal ECG at baseline who developed abnormal ECGs during the study.
| participants | Duloxetine |
|---|---|
| Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study | 3 |
Laboratory analytes were collected to assess adverse events which are listed in the reported adverse events section.
No measurements were reported for this outcome.
Response was defined as a \>= 50% reduction in 17-item Hamilton Depression rating scale (HAMD) scores. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
| participants | Duloxetine |
|---|---|
| Number of Participants Who Responded to Treatment by 12 Weeks | 90 |
Remission was defined as reaching a 17-item Hamilton Depression Rating Scale (HAMD) total score \<=7. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
| participants | Duloxetine |
|---|---|
| Number of Participants Who Reached Remission by 12 Weeks | 68 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duloxetine | — | 3/151 (2%) | 39/151 (25.8%) |
| Event | Duloxetine |
|---|---|
| Atrial fibrillationCardiac disorders | 1/151 |
| PneumoniaInfections and infestations | 1/151 |
| SepsisInfections and infestations | 1/151 |
| MyopathyMusculoskeletal and connective tissue disorders | 1/151 |
| Cerebral haemorrhageNervous system disorders | 1/151 |
| Renal failure acuteRenal and urinary disorders | 1/151 |
| Urinary retentionRenal and urinary disorders | 1/151 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/151 |
| Decubitus ulcerSkin and subcutaneous tissue disorders | 1/151 |
| Event | Duloxetine |
|---|---|
| NauseaGastrointestinal disorders | 6/151 |
| ConstipationGastrointestinal disorders | 5/151 |
| AptyalismGastrointestinal disorders | 3/151 |
| AstheniaGeneral disorders | 3/151 |
| HypercholesterolaemiaMetabolism and nutrition disorders | 3/151 |
| HeadacheNervous system disorders | 3/151 |
| SomnolenceNervous system disorders | 3/151 |
| VertigoEar and labyrinth disorders | 2/151 |
| DiarrhoeaGastrointestinal disorders | 2/151 |
| TremorNervous system disorders | 2/151 |
| Age Continuous(years) | Duloxetine |
|---|---|
| Mean | 63.6 ± 8.9 |
| Sex: Female, Male(Participants) | Duloxetine |
|---|---|
| Female | 85 |
| Male | 66 |
| Race/Ethnicity, Customized(participants) | Duloxetine |
|---|---|
| Caucasian | 151 |
| Region of Enrollment(participants) | Duloxetine |
|---|---|
| Italy | 151 |
| Current alcohol consumption by participants(participants) | Duloxetine |
|---|---|
| no | 130 |
| yes | 21 |
| Current use of tobacco products by participants(participants) | Duloxetine |
|---|---|
| no | 140 |
| yes | 11 |
| Depression in a distant relative of the participant(participants) | Duloxetine |
|---|---|
| no | 120 |
| yes | 1 |
| unknown | 30 |
| Depression in a second degree relative of the participant(participants) | Duloxetine |
|---|---|
| no | 126 |
| yes | 25 |
9 further baseline measures are reported on the registry.
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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