Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000376
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
1999-11-02
Brief Title:
Cognitive and Drug Therapy for Drug-Resistant Depression
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
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:
To develop an effective combined cognitive therapy CT plus drug treatment for patients with drug-resistant depression DRD ie depression that is refractory to medication To develop a manual for combined treatment for DRD that integrates three existing forms of CT CT for depression CT for personality disorders and CT for anxiety disorders and that specifies interventions for combining CT and medication when two therapists psychotherapist and pharmacotherapist provide the treatment To obtain outpatient randomized control pilot data on the clinical value of the combined CT plus drug treatment using the standard antidepressant desipramine DMI to obtain effect sizes and to determine if the treatment merits further investigation in a clinical trial To develop a therapist adherence measure for the combined treatment
Patients receive 1 of 2 treatments CT plus DMI n 18 or DMI plus Clinical Management n 12 The first 6 of the 18 CT plus DMI patients are treated in a pre-pilot phase before randomization begins All treatments continue for 6 months The major assessment battery is administered at intake 3 months 6 months and follow-up 6 months later All treatments are closely monitored via audiotapes and supervision for purposes of developing and refining the CT plus drug treatment The audiotapes are also used for development of the adherence measure The primary outcome measures are Hamilton Rating Scale for Depression scores Beck Depression Inventory scores percent of patients who achieve clinical remission of symptoms and percent showing attrition from treatment Compliance with the treatment regimens is also a targeted and measured outcome variable
Patients receive 1 of 2 treatments CT plus DMI n 18 or DMI plus Clinical Management n 12 The first 6 of the 18 CT plus DMI patients are treated in a pre-pilot phase before randomization begins All treatments continue for 6 months The major assessment battery is administered at intake 3 months 6 months and follow-up 6 months later All treatments are closely monitored via audiotapes and supervision for purposes of developing and refining the CT plus drug treatment The audiotapes are also used for development of the adherence measure The primary outcome measures are Hamilton Rating Scale for Depression scores Beck Depression Inventory scores percent of patients who achieve clinical remission of symptoms and percent showing attrition from treatment Compliance with the treatment regimens is also a targeted and measured outcome variable
Detailed Description:
To develop an effective combined cognitive therapy CT plus drug treatment for patients with drug-resistant depression DRD ie depression that is refractory to medication To develop a manual for combined treatment for DRD that integrates three existing forms of CT CT for depression CT for personality disorders and CT for anxiety disorders and that specifies interventions for combining CT and medication when two therapists psychotherapist and pharmacotherapist provide the treatment To obtain outpatient randomized control pilot data on the clinical value of the combined CT plus drug treatment using the standard antidepressant desipramine DMI to obtain effect sizes and to determine if the treatment merits further investigation in a clinical trial To develop a therapist adherence measure for the combined treatment
Patients receive 1 of 2 treatments CT plus DMI n 18 or DMI plus Clinical Management n 12 The first 6 of the 18 CT plus DMI patients are treated in a pre-pilot phase before randomization begins All treatments continue for 6 months The major assessment battery is administered at intake 3 months 6 months and follow-up 6 months later All treatments are closely monitored via audiotapes and supervision for purposes of developing and refining the CT plus drug treatment The audiotapes are also used for development of the adherence measure The primary outcome measures are Hamilton Rating Scale for Depression scores Beck Depression Inventory scores percent of patients who achieve clinical remission of symptoms and percent showing attrition from treatment Compliance with the treatment regimens is also a targeted and measured outcome variable
Patients receive 1 of 2 treatments CT plus DMI n 18 or DMI plus Clinical Management n 12 The first 6 of the 18 CT plus DMI patients are treated in a pre-pilot phase before randomization begins All treatments continue for 6 months The major assessment battery is administered at intake 3 months 6 months and follow-up 6 months later All treatments are closely monitored via audiotapes and supervision for purposes of developing and refining the CT plus drug treatment The audiotapes are also used for development of the adherence measure The primary outcome measures are Hamilton Rating Scale for Depression scores Beck Depression Inventory scores percent of patients who achieve clinical remission of symptoms and percent showing attrition from treatment Compliance with the treatment regimens is also a targeted and measured outcome variable
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 | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH052737 |
| R21MH052737 | NIH | None | None |