Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease

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

Population: All treated participants.

For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.

Time frame: baseline through 12 weeks

Population: All treated participants were included in the analysis population. 5 participants for standing measurement and 6 participants for supine measurements were excluded from calculation of change as they had either no baseline or no post-baseline measure.

For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.

Time frame: baseline through 12 weeks

Population: All treated participants were included in the analysis population. 6 participants were excluded from calculation of change as they had either no baseline or post-baseline measure.

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

Population: All treated participants with baseline and post-baseline data for \>= 1 visit for \>= 1 efficacy variable were included in the analyses (Full Analysis Set population). Last observation carried forward analysis. Excluded 2 participants (no baseline measure of PSQI) and 13 participants from calculation of change (absence of any post-baseline measure).

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

Population: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. 27 participants had no post baseline measure.

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

Population: All treated participants with both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with no baseline measure and 29 participants with no post baseline measure.

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

Population: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with only post-baseline data and 1 participant with only baseline data.

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

Population: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.

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

Population: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.

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

Population: All treated participants were included in the analysis population. Last observation carried forward analysis. One participant was excluded as no data for UKU were available and other participants were excluded as relevant due to absence of either baseline or post-baseline measure.

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

Population: All treated participants were included in the analysis population. Last observation carried forward analysis. Two participants were excluded from calculation of change as they had no post-baseline measure.

Laboratory analytes were collected to assess adverse events which are listed in the reported adverse events section.

Time frame: baseline through 12 weeks

Population: All enrolled participants for whom both baseline data and post-baseline data were available were included in the analyses.

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

Population: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.

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

Population: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.

Included were participants with normal ECG at baseline who developed abnormal ECGs during the study.

Time frame: baseline through 12 weeks

Population: All treated participants were included in the analysis population. 54 participants were excluded from calculation of change as they had abnormal ECG at baseline, no baseline measure, or no post-baseline measure.

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

Population: All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses.