Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000378
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
1999-11-02
Brief Title:
Antidepressant Treatment of Melancholia in Late Life
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Antidepressant Treatment of Melancholia in Late Ife
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 heshe will participate in a 6-month continuation phase in which heshe will continue to receive the same medication
An individual may be eligible for this study if heshe
Has unipolar major depression with some exceptions and is over 60 years old
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 heshe will participate in a 6-month continuation phase in which heshe will continue to receive the same medication
An individual may be eligible for this study if heshe
Has unipolar major depression with some exceptions and is over 60 years old
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH055716 | NIH | None | httpsreporternihgovquickSearchR01MH055716 |