Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021528
Status:
COMPLETED
Last Update Posted:
2009-09-25
First Post:
2001-07-20
Brief Title:
Sequenced Treatment Alternatives to Relieve Depression STARD
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
Sequenced Treatment Alternatives to Relieve Depression
Status:
COMPLETED
Status Verified Date:
2006-09
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:
STARD focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response Participants will first receive citalopram an SSRI medication if symptoms remain after 8-12 weeks of treatment up to four other levels of treatment will be offered including cognitive therapy and other medications There are no placebo treatments Some patients may require a combination of two or more treatments to obtain full benefit Participation could last from 15 to 27 months and involve up to 30 clinic visits Participants will be interviewed by telephone throughout the study about their symptoms daily functioning treatment side effects use of the health care system and satisfaction with treatment There will be a one-year follow up for participants once their depression has been successfully treated
Detailed Description:
The STARD project will enroll 4000 outpatients ages 18 -75 diagnosed with nonpsychotic Major Depressive Disorder Participants will be initially treated open label with citalopram the Level 1 treatment for a minimum of 8 weeks Patients who experience minimal benefit will be strongly encouraged to complete 12 weeks of treatment in order to maximize the chances of symptom remission unless no benefit at all is seen after 8 weeks All participants will also receive a brief depression educational program
At each level change participants will be asked to indicate the unacceptability of the potential treatment strategies eg to augment or to switch medications Participants will then be eligible for random assignment to one of the acceptable and medically safe treatment options
Level 2 Participants who either did not have an adequate response to or could not tolerate citalopram are eligible for Level 2 The Level 2 treatment strategies are
i Medication and Psychotherapy Switch switch to sertraline venlafaxineXR bupropionSR or cognitive therapy CT
ii Medication and Psychotherapy Augmentation add to citalopram either a buspirone b bupropionSR or c CT
iii Medication Only Switch or Medication Only Augmentation options are available for participants for whom CT is unacceptable
ivPsychotherapy Only Switch or Psychotherapy Only Augmentation options are available for participants for whom additional medication is unacceptable at this point in the study participants must be willing to continue citalopram
Level 2A Participants without a satisfactory response to their Level 2 treatment are eligible for random assignment to additional treatment at Level 2A if medically safe and acceptable Level 2A is included so that all participants entering Level 3 have had an opportunity to respond to at least 2 medications Level 2A consists of Medication Switch to one of two antidepressant medications venlafaxineXR or bupropion SR
Level 3 Participants without satisfactory response to Level 2 andif appropriate Level 2A are eligible for random assignment to one of the following treatments if acceptable and medically safe
i Medication Switch to a mirtazapine or b nortriptyline a tricyclic antidepressant
ii Medication Augmentation Add to current Level 2 or Level 2A medication either a lithium or b thyroid hormone T3
Level 4 Participants without an adequate response to Level 3 are eligible for random assignment to Level 4 treatment if acceptable and medically safe Level 4 includes two Medication Switch options to tranylcypromine a monoamine oxidase inhibitor MAOI or to mirtazapine plus venlafaxineXR
After Level 4 participants without an adequate response will discuss other acceptable treatment options with their physician
Once an adequate response is achieved at Levels 2 2A 3 or 4 participants are eligible to enter the 12-month follow-up during which time they will remain on their current treatments and will be asked about their symptoms and other relevant information monthly by telephone ONLY PATIENTS BEING TREATED AT THE PARTICIPATING CLINICS ARE ELIGIBLE FOR THIS STUDY
At each level change participants will be asked to indicate the unacceptability of the potential treatment strategies eg to augment or to switch medications Participants will then be eligible for random assignment to one of the acceptable and medically safe treatment options
Level 2 Participants who either did not have an adequate response to or could not tolerate citalopram are eligible for Level 2 The Level 2 treatment strategies are
i Medication and Psychotherapy Switch switch to sertraline venlafaxineXR bupropionSR or cognitive therapy CT
ii Medication and Psychotherapy Augmentation add to citalopram either a buspirone b bupropionSR or c CT
iii Medication Only Switch or Medication Only Augmentation options are available for participants for whom CT is unacceptable
ivPsychotherapy Only Switch or Psychotherapy Only Augmentation options are available for participants for whom additional medication is unacceptable at this point in the study participants must be willing to continue citalopram
Level 2A Participants without a satisfactory response to their Level 2 treatment are eligible for random assignment to additional treatment at Level 2A if medically safe and acceptable Level 2A is included so that all participants entering Level 3 have had an opportunity to respond to at least 2 medications Level 2A consists of Medication Switch to one of two antidepressant medications venlafaxineXR or bupropion SR
Level 3 Participants without satisfactory response to Level 2 andif appropriate Level 2A are eligible for random assignment to one of the following treatments if acceptable and medically safe
i Medication Switch to a mirtazapine or b nortriptyline a tricyclic antidepressant
ii Medication Augmentation Add to current Level 2 or Level 2A medication either a lithium or b thyroid hormone T3
Level 4 Participants without an adequate response to Level 3 are eligible for random assignment to Level 4 treatment if acceptable and medically safe Level 4 includes two Medication Switch options to tranylcypromine a monoamine oxidase inhibitor MAOI or to mirtazapine plus venlafaxineXR
After Level 4 participants without an adequate response will discuss other acceptable treatment options with their physician
Once an adequate response is achieved at Levels 2 2A 3 or 4 participants are eligible to enter the 12-month follow-up during which time they will remain on their current treatments and will be asked about their symptoms and other relevant information monthly by telephone ONLY PATIENTS BEING TREATED AT THE PARTICIPATING CLINICS ARE ELIGIBLE FOR THIS STUDY
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 |
|---|---|---|---|
| DSIR AT | None | None | None |