A Phase 4 interventional study of Duloxetine in Depression and Dysthymic Disorder, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 60 Years to 95 Years. Per ClinicalTrials.gov, last updated 2014-05-01.
Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Treatment
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.
HYPOTHESES:
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.
8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 30 is below the median of 84 across 6,869 interventional studies indexed under Depression.
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Exclusion Criteria:
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.
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.
Also known as: Cymbalta
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.
Time frame: Screen (0) and 12 weeks
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.
Time frame: Week 0 and 12
Change in the Treatment Emergent Symptom Scale (TESS) Total Score From Week 0 to Week 12.
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
Maximum Duloxetine Oral Dose
Maximum duloxetine oral dose
Time frame: Week 0, 1, 2, 4, 6, 8, 10, 12
| Milestone | Duloxetine |
|---|---|
| Started | 30 |
| Completed | 19 |
| Not completed | 11 |
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.
| units on a scale | Duloxetine |
|---|---|
| Change in Hamilton Rating Scale for Depression (HAM-D, 24-item) From 0 Weeks to 12 Weeks. | 8 ± 6.1 |
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.
| units on a scale | Duloxetine |
|---|---|
| Change in the Treatment Emergent Symptom Scale (TESS) Total Score From Week 0 to Week 12. | 5.2 ± 3.3 |
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.
| units on a scale | Duloxetine |
|---|---|
| Change in Cornell Dysthymia Rating Scale Scores From Week 0 to Week 12 | 28.8 ± 10.4 |
Maximum duloxetine oral dose
| mg | Duloxetine |
|---|---|
| Maximum Duloxetine Oral Dose | 101 ± 38.4 |
Collected over Assessments were completed once a week throughout the 12-week trial.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duloxetine | — | 0/30 (0%) | 7/30 (23.3%) |
| Event | Duloxetine |
|---|---|
| Constipation and AnorgasmiaGastrointestinal disorders | 1/30 |
| FallGeneral disorders | 1/30 |
| TremorNervous system disorders | 1/30 |
| DiarrheaGastrointestinal disorders | 1/30 |
| InsomniaNervous system disorders | 1/30 |
| NauseaGastrointestinal disorders | 1/30 |
| SedationNervous system disorders | 1/30 |
| Age, Categorical(Participants) | Duloxetine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 20 |
| Age, Continuous(years) | Duloxetine |
|---|---|
| Mean | 70.7 ± 7.6 |
| Sex: Female, Male(Participants) | Duloxetine |
|---|---|
| Female | 17 |
| Male | 13 |
| Region of Enrollment(participants) | Duloxetine |
|---|---|
| United States | 30 |
The record gives a start of Jan 2006, a primary completion of Sep 2010 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.
Results were first posted in May 2014, 3 years 8 months after primary completion.
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Studies of the drug tested here: Duloxetine
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