Trial Outcomes & Findings for The Effects of Sertraline on Depression in Parkinson's Disease (NCT NCT01437189)

Results Overview

The minimum and maximum value of HAMD is 0 and 96 respectively. The higher score means worse severity of depression. Combined with reducing scores rate of HAMD, there are four grades: heal (HAMD is lower than 8 or reducing rate is higher than 75%), excellent utility (reducing rate is between 50% and 75%), utility (reducing rate is between 25% and 50%) and nullity (reducing rate is lower than 25%).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

baseline, 8 weeks (endpoint)

Results posted on

2024-01-30

Participant Flow

Start on August/01 2011 Location: the second affiliated hospital of Zhejiang University, School of medicine.

Participant milestones

Participant milestones
Measure	Parkinson's Disease Patients With Depression This arm received treatment of Sertraline. Sertraline: Starting dose 25mg/day for 1 week, then increasing to 50mg/day, add on 50mg each time when the depressive symptoms are not improved, at 2-week intervals. Maximum: 200mg/day. Maintenance: lowest effective dose.
Overall Study STARTED	35
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Parkinson's Disease Patients With Depression This arm received treatment of Sertraline. Sertraline: Starting dose 25mg/day for 1 week, then increasing to 50mg/day, add on 50mg each time when the depressive symptoms are not improved, at 2-week intervals. Maximum: 200mg/day. Maintenance: lowest effective dose.
Overall Study Adverse Event	3
Overall Study Lack of Efficacy	4
Overall Study Withdrawal by Subject	8

Baseline Characteristics

The Effects of Sertraline on Depression in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parkinson's Disease Patients With Depression n=35 Participants Sertraline: Starting dose 25mg/day for 1 week, then increasing to 50mg/day, add on 50mg each time when the depressive symptoms are not improved, at 2-week intervals. Maximum: 200mg/day. Maintenance: lowest effective dose.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment China	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 8 weeks (endpoint)

The minimum and maximum value of HAMD is 0 and 96 respectively. The higher score means worse severity of depression. Combined with reducing scores rate of HAMD, there are four grades: heal (HAMD is lower than 8 or reducing rate is higher than 75%), excellent utility (reducing rate is between 50% and 75%), utility (reducing rate is between 25% and 50%) and nullity (reducing rate is lower than 25%).

Outcome measures

Outcome measures
Measure	Parkinson's Disease Patients With Depression n=20 Participants This arm received treatment of Sertraline. Sertraline: Starting dose 25mg/day for 1 week, then increasing to 50mg/day, add on 50mg each time when the depressive symptoms are not improved, at 2-week intervals. Maximum: 200mg/day. Maintenance: lowest effective dose. after 8 weeks. the score of Hamilton Depression Rating Scale was compared.
Change From Baseline in Hamilton Depression Rating Scale (HAMD) baseline	48.1 score on a scale Standard Error 7.4
Change From Baseline in Hamilton Depression Rating Scale (HAMD) endpoint	35.5 score on a scale Standard Error 10.5

SECONDARY outcome

Timeframe: Baseline, 8 weeks (endpoint)

The minimum and maximum value of PDQ-39 is 0 and 116respectively. The higher score means worse severity of quality of life.

Outcome measures

Outcome measures
Measure	Parkinson's Disease Patients With Depression n=20 Participants This arm received treatment of Sertraline. Sertraline: Starting dose 25mg/day for 1 week, then increasing to 50mg/day, add on 50mg each time when the depressive symptoms are not improved, at 2-week intervals. Maximum: 200mg/day. Maintenance: lowest effective dose. after 8 weeks. the score of Hamilton Depression Rating Scale was compared.
Change From Baseline in Questionnaire of PDQ-39, baseline	51 units on a scale Standard Deviation 10.5
Change From Baseline in Questionnaire of PDQ-39, endpoint	46 units on a scale Standard Deviation 9.7

Adverse Events

Parkinson's Disease Patients With Depression

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Parkinson's Disease Patients With Depression n=35 participants at risk This arm received treatment of Sertraline. Sertraline: Starting dose 25mg/day for 1 week, then increasing to 50mg/day, add on 50mg each time when the depressive symptoms are not improved, at 2-week intervals. Maximum: 200mg/day. Maintenance: lowest effective dose.
Nervous system disorders dizziness	5.7% 2/35 • Number of events 2 • Adverse event data were collected for each visit from administration to endpoint.
Gastrointestinal disorders nausea	2.9% 1/35 • Number of events 1 • Adverse event data were collected for each visit from administration to endpoint.

Additional Information

Bo Wang

ZhejiangU

Phone: 87784711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place