Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222820
Status:
COMPLETED
Last Update Posted:
2005-09-22
First Post:
2005-09-13
Brief Title:
Depression The Search for Treatment-Relevant Phenotypes-Pilot Study
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Depression The Search for Treatment-Relevant Phenotypes
Status:
COMPLETED
Status Verified Date:
2005-09
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:
We are doing this pilot study to learn more about four aspects of treating depression
1 The features of a depressed persons mood and anxiety and how these features affect a persons capacity to get better and stay better
2 If depressed people with certain features of mood and anxiety respond better to therapy medication or a combination of therapy and medication
3 Whether or not a persons personality traits affect how they respond to treatment
4 The gene involved in processing antidepressant medication
1 The features of a depressed persons mood and anxiety and how these features affect a persons capacity to get better and stay better
2 If depressed people with certain features of mood and anxiety respond better to therapy medication or a combination of therapy and medication
3 Whether or not a persons personality traits affect how they respond to treatment
4 The gene involved in processing antidepressant medication
Detailed Description:
This pilot study is an experimental investigation designed so that consenting subjects are randomly assigned to pharmacotherapeutic or psychotherapeutic interventions for depression
For the initial phase of treatment subjects will be randomly assigned to treatment with an SSRI escitalopram oxalate or citalopram hydrobromide or with interpersonal psychotherapy IPT Escitalopram will be prescribed for all patients randomized to the medication arm of the study unless the study psychiatrist determines that citalopram is more clinically appropriate Escitalopram and citalopram are FDA-Approved SSRI antidepressants indicated for the treatment of depression In order to optimize outcomes and emulate usual clinical practice subjects who do not meet response criteria defined as a 50 reduction in baseline Hamilton Rating Scale for Depression HRS-D or meet stabilization criteria defined as a mean HRS-D 7 for 3 weeks at acute phase Visit 7 or Visit 13 of treatment will have the other treatment added Subjects who meet stabilization criteria mean HRS-D 7 for 3 weeks at any time between acute phase Visit 13 and 21 will enter the 6-month continuation phase and continue with the treatment that led to their stabilization Subjects who have not met stabilization criteria by acute phase Visit 21 will remain in active treatment and be offered alternative pharmacotherapy Subjects who have not responded by acute phase Visit 32 will be discontinued from the protocol and referred for alternative treatment and care
For the initial phase of treatment subjects will be randomly assigned to treatment with an SSRI escitalopram oxalate or citalopram hydrobromide or with interpersonal psychotherapy IPT Escitalopram will be prescribed for all patients randomized to the medication arm of the study unless the study psychiatrist determines that citalopram is more clinically appropriate Escitalopram and citalopram are FDA-Approved SSRI antidepressants indicated for the treatment of depression In order to optimize outcomes and emulate usual clinical practice subjects who do not meet response criteria defined as a 50 reduction in baseline Hamilton Rating Scale for Depression HRS-D or meet stabilization criteria defined as a mean HRS-D 7 for 3 weeks at acute phase Visit 7 or Visit 13 of treatment will have the other treatment added Subjects who meet stabilization criteria mean HRS-D 7 for 3 weeks at any time between acute phase Visit 13 and 21 will enter the 6-month continuation phase and continue with the treatment that led to their stabilization Subjects who have not met stabilization criteria by acute phase Visit 21 will remain in active treatment and be offered alternative pharmacotherapy Subjects who have not responded by acute phase Visit 32 will be discontinued from the protocol and referred for alternative treatment and care
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