Trial Outcomes & Findings for Duloxetine Treatment in Elderly With Dysthymia (NCT NCT01852383)

Results Overview

The research rater completed the 24-item Hamilton Rating Scale for Depression (HAM-D) and documented the scores on each visit. Hamilton Rating Scale for Depression scores range from 0-50 with low scores or decreasing scores representing decreased severity and better outcome, and higher scores or increasing scores representing more severe depressive symptoms and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Screen (0) and 12 weeks

Results posted on

2014-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Duloxetine A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily. At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication. Administration will be as a single a.m. dose.
Overall Study STARTED	30
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Duloxetine Treatment in Elderly With Dysthymia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine n=30 Participants A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily. At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication. Administration will be as a single a.m. dose.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Age, Continuous	70.7 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Screen (0) and 12 weeks

The research rater completed the 24-item Hamilton Rating Scale for Depression (HAM-D) and documented the scores on each visit. Hamilton Rating Scale for Depression scores range from 0-50 with low scores or decreasing scores representing decreased severity and better outcome, and higher scores or increasing scores representing more severe depressive symptoms and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score.

Outcome measures

Outcome measures
Measure	Duloxetine n=30 Participants A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily. At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication. Administration will be as a single a.m. dose.
Change in Hamilton Rating Scale for Depression (HAM-D, 24-item) From 0 Weeks to 12 Weeks.	8 units on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: Week 0 and 12

Cornell Dysthymia Rating Scale scores from range 0-64. Lower or decreasing scores represent decreased severity and a better outcome, while higher or increasing scores represent more severe depression and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score.

Outcome measures

Outcome measures
Measure	Duloxetine n=30 Participants A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily. At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication. Administration will be as a single a.m. dose.
Change in Cornell Dysthymia Rating Scale Scores From Week 0 to Week 12	28.8 units on a scale Standard Deviation 10.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 and 12 weeks

The Treatment Emergent Symptom Scale (TESS) documents the presence of common side effects. There are 26 items and the total score range is 0-26. Low scores or decrease in scores represent less side effects and high scores or increase in scores represent more side effects. The change in side effect severity scores was calculated by subtracting the Week 12 score from the Week 0 score.

Outcome measures

Outcome measures
Measure	Duloxetine n=30 Participants A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily. At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication. Administration will be as a single a.m. dose.
Change in the Treatment Emergent Symptom Scale (TESS) Total Score From Week 0 to Week 12.	5.2 units on a scale Standard Deviation 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0, 1, 2, 4, 6, 8, 10, 12

Maximum duloxetine oral dose

Outcome measures

Outcome measures
Measure	Duloxetine n=30 Participants A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily. At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication. Administration will be as a single a.m. dose.
Maximum Duloxetine Oral Dose	101 mg Standard Deviation 38.4

Adverse Events

Duloxetine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Duloxetine n=30 participants at risk A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily. At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication. Administration will be as a single a.m. dose.
Gastrointestinal disorders Constipation and Anorgasmia	3.3% 1/30 • Number of events 1 • Assessments were completed once a week throughout the 12-week trial.
General disorders Fall	3.3% 1/30 • Number of events 1 • Assessments were completed once a week throughout the 12-week trial.
Nervous system disorders Tremor	3.3% 1/30 • Number of events 1 • Assessments were completed once a week throughout the 12-week trial.
Gastrointestinal disorders Diarrhea	3.3% 1/30 • Number of events 1 • Assessments were completed once a week throughout the 12-week trial.
Nervous system disorders Insomnia	3.3% 1/30 • Number of events 1 • Assessments were completed once a week throughout the 12-week trial.
Gastrointestinal disorders Nausea	3.3% 1/30 • Number of events 1 • Assessments were completed once a week throughout the 12-week trial.
Nervous system disorders Sedation	3.3% 1/30 • Number of events 1 • Assessments were completed once a week throughout the 12-week trial.

Additional Information

Dr. D.P. Devanand

New York State Psychiatric Institute

Phone: (646) 774-8658

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place