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Trial record 24 of 336 for:    "Depressive Disorder" [DISEASE] AND Rating AND Reuptake

Duloxetine Treatment in Elderly With Dysthymia

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ClinicalTrials.gov Identifier: NCT01852383
Recruitment Status : Completed
First Posted : May 13, 2013
Results First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depression
Dysthymic Disorder
Intervention Drug: Duloxetine
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Duloxetine
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 30
Completed 19
Not Completed 11
Arm/Group Title Duloxetine
Hide Arm/Group Description

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 Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  33.3%
>=65 years
20
  66.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
70.7  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
17
  56.7%
Male
13
  43.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Change in Hamilton Rating Scale for Depression (HAM-D, 24-item) From 0 Weeks to 12 Weeks.
Time Frame Screen (0) and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:

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 Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
8  (6.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in Cornell Dysthymia Rating Scale Scores From Week 0 to Week 12
Hide Description 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.
Time Frame Week 0 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:

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.

Administration was as a single a.m. dose.

Duloxetine: Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale, Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale.

Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
28.8  (10.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.
Method ANCOVA
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Change in the Treatment Emergent Symptom Scale (TESS) Total Score From Week 0 to Week 12.
Hide Description 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.
Time Frame 0 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:

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 Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.2  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.1
Comments Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.
Method Corrlation
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Maximum Duloxetine Oral Dose
Hide Description Maximum duloxetine oral dose
Time Frame Week 0, 1, 2, 4, 6, 8, 10, 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:

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.

Administration was as a single a.m. dose.

Duloxetine: Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale, Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale.

Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: mg
101  (38.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine
Comments Correlation of maximum duloxetine dose with change in Hamilton Depression Rating Scale scores from 0 Weeks to 12 Weeks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Pearson correlation coefficient. Not adjusted for multiple comparisons. Alpha=0.05 for statistical significance threshold.
Method Pearson correlation
Comments [Not Specified]
Time Frame Assessments were completed once a week throughout the 12-week trial.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine
Hide Arm/Group Description

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.

All-Cause Mortality
Duloxetine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duloxetine
Affected / at Risk (%) # Events
Total   7/30 (23.33%)    
Gastrointestinal disorders   
Constipation and Anorgasmia   1/30 (3.33%)  1
Diarrhea   1/30 (3.33%)  1
Nausea   1/30 (3.33%)  1
General disorders   
Fall   1/30 (3.33%)  1
Nervous system disorders   
Tremor   1/30 (3.33%)  1
Insomnia   1/30 (3.33%)  1
Sedation   1/30 (3.33%)  1
Indicates events were collected by systematic assessment