Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-29 @ 6:02 PM
Study NCT ID:
NCT00222820
Status:
COMPLETED
Last Update Posted:
2005-09-22
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depression: The Search for Treatment-Relevant Phenotypes-Pilot Study
Sponsor:
University of Pittsburgh
Organization:
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 person's mood and anxiety and how these features affect a person's 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 person's personality traits affect how they respond to treatment.
4. The gene involved in processing antidepressant medication
1. The features of a depressed person's mood and anxiety and how these features affect a person's 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 person's 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: