search
Back to results

Duloxetine Treatment in Elderly With Dysthymia

Primary Purpose

Depression, Dysthymic Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Duloxetine, Antidepressant, Depression, Dysthymic Disorder, Side Effects, Elderly

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of dysthymic disorder (SCID and DSM-IV)
  • Age 60 - 95
  • Mini-Mental State Score ≥ 24
  • 24-item Hamilton Rating Scale for Depression score 12-25
  • Willing and capable of giving informed consent

Exclusion Criteria:

  • Current major depressive episode (SCID and DSM-IV)
  • Alcohol or substance dependence during the last year (SCID and DSM-IV)
  • Bipolar disorder, schizophrenia and other psychotic disorders(SCID and DSM-IV)
  • Clinical stroke, dementia, Huntington's disease, epilepsy or other major neurological disease
  • Acute unstable medical conditions
  • Active suicidal ideation or plan
  • Non-response to duloxetine (minimum 90 mg/day for 6 weeks) during the past year
  • A positive urine drug screen for substances of abuse or dependence
  • Sensitivity with intolerability to duloxetine
  • Use of other medications that may interact with duloxetine, including inhibitors of cytochrome P450 1A2 (CYP1A2) and cytochrome P450 2D6 (CYP2D6), e.g., quinolone antibiotics and type 1-C anti-arrhythmics. Several antidepressant medications, including most SSRIs, are inhibitors of CYP2D6 but these medications are not permitted during this antidepressant treatment trial.
  • Patients with hypertension (BP >140/90 mm Hg on 2 consecutive measurements). For patients with treated hypertension and BP >140/90, written approval must be obtained from patient's internist allowing them to participate in this study.
  • Known liver damage or disease

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duloxetine

Arm 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.

Outcomes

Primary Outcome Measures

Change in Hamilton Rating Scale for Depression (HAM-D, 24-item) From 0 Weeks to 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.

Secondary Outcome Measures

Change in Cornell Dysthymia Rating Scale Scores From Week 0 to Week 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.

Full Information

First Posted
May 8, 2013
Last Updated
April 1, 2014
Sponsor
New York State Psychiatric Institute
Collaborators
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT01852383
Brief Title
Duloxetine Treatment in Elderly With Dysthymia
Official Title
An Open Treatment Trial of Duloxetine in Elderly Patients With Dysthymic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dysthymic disorder (DD) denotes chronic depression with fewer symptoms than major depressive disorder (MDD), and it affects ~ 2-4 % of adults with a similar prevalence in the elderly. In the elderly, dysthymic disorder (DD) has been shown to be associated with suffering and disability. The differences between young adult and elderly DD patients indicate that findings obtained in young adults with DD cannot be extrapolated to elderly DD patients who need to be studied separately. Data from epidemiologic studies support this view. In contrast to the data in young adult DD patients, there is a paucity of controlled data on the treatment of elderly DD patients. In our center, a double-masked, placebo-controlled study of 91 elderly DD patients did not find significant superiority for fluoxetine over placebo with response rates of 27.3% for fluoxetine and 19.6% for placebo in intent-to-treat analyses, and response rates of 37.5% for fluoxetine and 23.1% for placebo in completer analyses. Given the relative failure of selective serotonin reuptake inhibitor (SSRIs) to treat geriatric DD effectively, the investigators decided to evaluate the dual reuptake inhibitor, venlafaxine. The investigators earlier completed an investigator-initiated, open-label 12-week venlafaxine (Effexor XR) trial. Of 23 elderly DD patients, 18 completed the trial. Fourteen (60.9%) were responders in intent-to-treat analyses with the last observation carried forward, and 77.8% were responders in completer analyses. Nearly half the sample (47.8%) met criteria for remission. In the intent-to-treat sample, increased severity of depression at baseline was associated with superior response and the presence of cardiovascular disease was associated with poorer response. These results with venlafaxine indicate that further treatment studies of dual serotonin-norepinephrine reuptake inhibitors like duloxetine are warranted in elderly patients with dysthymic disorder.
Detailed Description
HYPOTHESES: Duloxetine will reduce depressive symptomatology over a period of 12 weeks in elderly DD patients. Duloxetine-treated dysthymic patients will have significant improvement in measures of overall functioning. This pilot trial enrolled 30 patients ≥ 60 years old with dysthymic disorder. Patients were recruited by clinician referral and by radio or newspaper advertisements that offered free evaluation by experienced clinicians for participation in clinical trials in the Adult and Late Life Depression Clinic at the New York State Psychiatric Institute. After a telephone screen to rule out exclusions for enrollment in the clinic, a psychiatrist conducted a detailed evaluation and completed the Cumulative Illness Rating Scale (CIRS)-Geriatric [CIRS-G]. Patients with a provisional clinical diagnosis of dysthymic disorder were interviewed by a research rater (social worker or nurse) with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) Axis I disorders- Patient edition (SCID-P). Based on the psychiatrist's evaluation and the SCID-P interview, a consensus DSM-IV diagnosis was made at a staff conference.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Dysthymic Disorder
Keywords
Duloxetine, Antidepressant, Depression, Dysthymic Disorder, Side Effects, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
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. The research rater completed a SCID-P at baseline and the 24-item HAM-D at each visit, and the patient completed the Beck Depression Inventory-II at each visit. Adverse events: All adverse events and serious adverse events were documented. The maximum duration of delay before active treatment (medication or psychotherapy) was 1 week. Dropout: Patients who had a CGI score of 6 or 7 for two weeks during the second half of the study were dropped by the investigator from the trial.
Primary Outcome Measure Information:
Title
Change in Hamilton Rating Scale for Depression (HAM-D, 24-item) From 0 Weeks to 12 Weeks.
Description
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.
Time Frame
Screen (0) and 12 weeks
Secondary Outcome Measure Information:
Title
Change in Cornell Dysthymia Rating Scale Scores From Week 0 to Week 12
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
Other Pre-specified Outcome Measures:
Title
Change in the Treatment Emergent Symptom Scale (TESS) Total Score From Week 0 to Week 12.
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
Title
Maximum Duloxetine Oral Dose
Description
Maximum duloxetine oral dose
Time Frame
Week 0, 1, 2, 4, 6, 8, 10, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of dysthymic disorder (SCID and DSM-IV) Age 60 - 95 Mini-Mental State Score ≥ 24 24-item Hamilton Rating Scale for Depression score 12-25 Willing and capable of giving informed consent Exclusion Criteria: Current major depressive episode (SCID and DSM-IV) Alcohol or substance dependence during the last year (SCID and DSM-IV) Bipolar disorder, schizophrenia and other psychotic disorders(SCID and DSM-IV) Clinical stroke, dementia, Huntington's disease, epilepsy or other major neurological disease Acute unstable medical conditions Active suicidal ideation or plan Non-response to duloxetine (minimum 90 mg/day for 6 weeks) during the past year A positive urine drug screen for substances of abuse or dependence Sensitivity with intolerability to duloxetine Use of other medications that may interact with duloxetine, including inhibitors of cytochrome P450 1A2 (CYP1A2) and cytochrome P450 2D6 (CYP2D6), e.g., quinolone antibiotics and type 1-C anti-arrhythmics. Several antidepressant medications, including most SSRIs, are inhibitors of CYP2D6 but these medications are not permitted during this antidepressant treatment trial. Patients with hypertension (BP >140/90 mm Hg on 2 consecutive measurements). For patients with treated hypertension and BP >140/90, written approval must be obtained from patient's internist allowing them to participate in this study. Known liver damage or disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davangere Devanand, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8666563
Citation
Nobler MS, Devanand DP, Kim MK, Fitzsimons LM, Singer TM, Turret N, Sackeim HA, Roose SP. Fluoxetine treatment of dysthymia in the elderly. J Clin Psychiatry. 1996 Jun;57(6):254-6.
Results Reference
background
PubMed Identifier
15533993
Citation
Devanand DP, Juszczak N, Nobler MS, Turret N, Fitzsimons L, Sackeim HA, Roose SP. An open treatment trial of venlafaxine for elderly patients with dysthymic disorder. J Geriatr Psychiatry Neurol. 2004 Dec;17(4):219-24. doi: 10.1177/0891988704269818.
Results Reference
background
PubMed Identifier
15653941
Citation
Devanand DP, Nobler MS, Cheng J, Turret N, Pelton GH, Roose SP, Sackeim HA. Randomized, double-blind, placebo-controlled trial of fluoxetine treatment for elderly patients with dysthymic disorder. Am J Geriatr Psychiatry. 2005 Jan;13(1):59-68. doi: 10.1176/appi.ajgp.13.1.59.
Results Reference
background
PubMed Identifier
17590215
Citation
Wise TN, Wiltse CG, Iosifescu DV, Sheridan M, Xu JY, Raskin J. The safety and tolerability of duloxetine in depressed elderly patients with and without medical comorbidity. Int J Clin Pract. 2007 Aug;61(8):1283-93. doi: 10.1111/j.1742-1241.2007.01476.x. Epub 2007 Jun 22.
Results Reference
background

Learn more about this trial

Duloxetine Treatment in Elderly With Dysthymia

We'll reach out to this number within 24 hrs