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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

Tracking Information
First Submitted Date  ICMJE May 8, 2013
First Posted Date  ICMJE May 13, 2013
Results First Submitted Date  ICMJE December 5, 2013
Results First Posted Date  ICMJE May 1, 2014
Last Update Posted Date May 1, 2014
Study Start Date  ICMJE January 2006
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2014)
Change in Hamilton Rating Scale for Depression (HAM-D, 24-item) From 0 Weeks to 12 Weeks. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2013)
Hamilton Rating Scale for Depression (24-item) [ Time Frame: Screen (0), 1, 4, 8, and 12 weeks ]
The research rater completed the 24-item Hamilton Rating Scale for Depression (HAM-D) and documented the scores on each visit.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2014)
Change in Cornell Dysthymia Rating Scale Scores From Week 0 to Week 12 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 1, 2014)
  • Change in the Treatment Emergent Symptom Scale (TESS) Total Score From Week 0 to Week 12. [ Time Frame: 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.
  • Maximum Duloxetine Oral Dose [ Time Frame: Week 0, 1, 2, 4, 6, 8, 10, 12 ]
    Maximum duloxetine oral dose
Original Other Pre-specified Outcome Measures
 (submitted: May 10, 2013)
  • Beck Depression Inventory-II (BDI) [ Time Frame: 0 (screen), 1, 4, 8, and 12 weeks ]
    The patient completed the Beck Depression Inventory-II (BDI) on each visit and the rater documented the scores.
  • Mini Mental State exam [ Time Frame: 0 (screen) and 12 weeks ]
    The rater completed the scores at initial evaluation and at last visit and documented the scores.
  • World Health Organization Disability Assessment Schedule II (WHODASII) [ Time Frame: 0 (screen) and 12 weeks ]
    The rater completed the scores at initial evaluation and at last visit and documented the scores.
  • Side effect ratings using the Treatment Emergent Symptom Scale (TESS) [ Time Frame: 0(screen), 1, 4, 8, and 12 weeks ]
    The study psychiatrist completed Side effect ratings using the Treatment Emergent Symptom Scale (TESS) and documented the scores on each visit.
  • Clinical Global Impression (CGI) scale [ Time Frame: 0 (screen), 1, 4, 8, and 12 weeks ]
    The study psychiatrist completed Clinical Global Impression (CGI) scale and documented the scores on each visit.
 
Descriptive Information
Brief Title  ICMJE Duloxetine Treatment in Elderly With Dysthymia
Official Title  ICMJE An Open Treatment Trial of Duloxetine in Elderly Patients With Dysthymic Disorder
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:

  1. Duloxetine will reduce depressive symptomatology over a period of 12 weeks in elderly DD patients.
  2. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Dysthymic Disorder
Intervention  ICMJE Drug: 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. 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.

Other Name: Cymbalta
Study Arms  ICMJE Experimental: 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.

Administration was as a single a.m. dose.

Intervention: Drug: Duloxetine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2013)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01852383
Other Study ID Numbers  ICMJE 6143R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Davangere Devanand, M.D. Columbia University
PRS Account New York State Psychiatric Institute
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP