- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000378
Antidepressant Treatment of Melancholia in Late Life
Antidepressant Treatment of Melancholia in Late :Ife
The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression.
SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients.
Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication.
An individual may be eligible for this study if he/she:
Has unipolar major depression (with some exceptions) and is over 60 years old.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To compare the efficacy and safety of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who meet Diagnostic and Statistical Manuel-IV criteria for unipolar major depression, excluding patients who meet criteria for psychotic or atypical subtype. To test the hypothesis that medication condition interacts with diagnostic subtype (melancholic vs non-melancholic) in determining antidepressant response. To examine the roles of symptom severity and alternative diagnostic subtyping in contributing to this pattern.
SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for depressed patients with melancholia. This issue is of particular concern in late-life major depression. SSRIs have important safety advantages with respect to overdose and a benign cardiovascular profile. Furthermore, the SSRIs do not have significant anticholinergic effects, and appear to be better tolerated than the TCAs. Perhaps most important, the SSRIs currently are prescribed widely as the medication treatment of first choice for major depression in late life. Therefore, if it were determined that SSRIs are considerably less effective than TCAs in the treatment of melancholia in the elderly, there would be significant ramifications for clinical practice.
Randomization to sertraline (a SSRI) or nortriptyline (a TCA) is stratified by the presence or absence of melancholia. Outcome measures for the 12-week acute phase include clinician and patient ratings of symptoms, side effects, and an evaluation of the health-related quality of life (HRQOL). At the end of the acute treatment phase, patients who meet criteria for clinical response participate in a 6-month continuation phase.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- 1051 Riverside Drive
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-
Patients must have:
Unipolar major depression (per Diagnostic and Statistical Manuel-IV criteria) with or without melancholia.
Exclusion Criteria:
-
Patients with the following symptoms or conditions are excluded:
Psychotic or atypical subtype of unipolar major depression.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: sertaline
patients randomized to sertraline 12 week trial does up to 200mgs
|
12 week trial dose up to 200mgs
|
Active Comparator: nortriptyline
patients randomized to nortriptyline dose adjusted to therapeutic level
|
12 week trial dose adjusted to therapeutic level
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HAMILTON Rating Scale for DEPRESSION Range
Time Frame: BASELINE COMPARED TO 12 WEEK MEASUREMENT
|
Hamilton scale range 0-40, values below 7 are considered normal.
the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement
|
BASELINE COMPARED TO 12 WEEK MEASUREMENT
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Steven P. Roose, MD, New York State Psychiatric Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Depression
- Female
- Human
- Male
- Aged
- Sertraline
- Serotonin Uptake Inhibitors
- Nortriptyline
- Middle Age
- Serotonin Uptake Inhibitors -- *therapeutic use
- Antidepressive Agents, Tricyclic
- Antidepressive Agents, Tricyclic -- *therapeutic use
- Antidepressive Agents, Tricyclic -- adverse effects
- Depression -- *drug therapy
- Nortriptyline -- *therapeutic use
- Nortriptyline -- adverse effects
- Sertraline -- *therapeutic use
- Sertraline -- adverse effects
- Serotonin Uptake Inhibitors -- adverse effects
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Adrenergic Uptake Inhibitors
- Sertraline
- Nortriptyline
Other Study ID Numbers
- #3105
- R01MH055716 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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