Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012558
Status:
COMPLETED
Last Update Posted:
2007-05-04
First Post:
2001-03-13
Brief Title:
Systematic Treatment Enhancement Program for Bipolar Disorder STEP-BD
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
Systematic Treatment Enhancement Program for Bipolar Disorder STEP-BD
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A long-term study of current treatments for bipolar disorder including medications and psychosocial therapies
Detailed Description:
STEP-BD is evaluating all the best-practice treatment options used for bipolar disorder mood-stabilizing medications antidepressants atypical antipsychotics and psychosocial interventions - or talk therapies - including Cognitive Behavioral Therapy Family-focused Therapy Interpersonal and Social Rhythm Therapy and Collaborative Care psychoeducation
There are two kinds of treatment pathways in STEP-BD and participants may have the opportunity to take part in both The medications and psychosocial interventions provided in these pathways are considered among the best choices of treatment for bipolar disorder in everyday clinical practice
In the Best Practice Pathway participants are followed by a STEP-BD certified doctor and all treatment choices are individualized Everyone enrolled in STEP-BD may participate in this pathway Participants and their doctors work together to decide on the best treatment plans and to change these plans if needed Also anyone who wishes to stay on his or her current treatment upon entering STEP-BD may do so in this pathway Adolescents and adults age 15 years and older may participate in the Best Practice Pathway
For adults age 18 and older another way to participate is in the STEP-BD Randomized Care Pathways Depending on their symptoms participants may be offered treatment in one or more of these pathways during the course of the study The participants remain on mood-stabilizing medication However because doctors are uncertain which of several treatment strategies work best for bipolar disorder another medication andor talk therapy may be added Each Randomized Care Pathway involves a different set of these additional treatments
Unlike in the Best Practice Pathway the participants in the Randomized Care Pathways are randomly assigned to treatments Also in some cases neither the participant nor the doctor will be told which of the different medications is being added This is called a double-blind study and is done so that the medication effects can be evaluated objectively without any unintended bias that may come from knowing what has been assigned Participants will not be assigned medications that they have had bad reactions to in the past that they are strongly opposed to or that the doctor feels are unsuitable for them The medications participants may be randomly assigned to in the Randomized Care Pathways are free of charge There are other treatment options for participants if they do not respond well to the treatment assigned to them Also participants may return to the Best Practice Pathway at any time About 1500 individuals will be enrolled in at least one Randomized Care Pathway during their period of participation in STEP-BD
It is important to note that STEP-BD provides continuity of care For example if a participant starts out in the Best Practice Pathway and later chooses to enter one of the Randomized Care Pathways he or she continues with the same STEP-BD doctor and treatment team Then after completing the Randomized Care Pathway the participant may return to the Best Practice Pathway for ongoing individually-tailored treatment
There are two kinds of treatment pathways in STEP-BD and participants may have the opportunity to take part in both The medications and psychosocial interventions provided in these pathways are considered among the best choices of treatment for bipolar disorder in everyday clinical practice
In the Best Practice Pathway participants are followed by a STEP-BD certified doctor and all treatment choices are individualized Everyone enrolled in STEP-BD may participate in this pathway Participants and their doctors work together to decide on the best treatment plans and to change these plans if needed Also anyone who wishes to stay on his or her current treatment upon entering STEP-BD may do so in this pathway Adolescents and adults age 15 years and older may participate in the Best Practice Pathway
For adults age 18 and older another way to participate is in the STEP-BD Randomized Care Pathways Depending on their symptoms participants may be offered treatment in one or more of these pathways during the course of the study The participants remain on mood-stabilizing medication However because doctors are uncertain which of several treatment strategies work best for bipolar disorder another medication andor talk therapy may be added Each Randomized Care Pathway involves a different set of these additional treatments
Unlike in the Best Practice Pathway the participants in the Randomized Care Pathways are randomly assigned to treatments Also in some cases neither the participant nor the doctor will be told which of the different medications is being added This is called a double-blind study and is done so that the medication effects can be evaluated objectively without any unintended bias that may come from knowing what has been assigned Participants will not be assigned medications that they have had bad reactions to in the past that they are strongly opposed to or that the doctor feels are unsuitable for them The medications participants may be randomly assigned to in the Randomized Care Pathways are free of charge There are other treatment options for participants if they do not respond well to the treatment assigned to them Also participants may return to the Best Practice Pathway at any time About 1500 individuals will be enrolled in at least one Randomized Care Pathway during their period of participation in STEP-BD
It is important to note that STEP-BD provides continuity of care For example if a participant starts out in the Best Practice Pathway and later chooses to enter one of the Randomized Care Pathways he or she continues with the same STEP-BD doctor and treatment team Then after completing the Randomized Care Pathway the participant may return to the Best Practice Pathway for ongoing individually-tailored treatment
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 |