Depression Clinical Trial
Official title:
An Open Treatment Trial of Duloxetine in Elderly Patients With Dysthymic Disorder
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:
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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