Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220623
Status:
UNKNOWN
Last Update Posted:
2005-09-22
First Post:
2005-09-16
Brief Title:
Efficacy of 18-Months of Antidepressive Medication Plus CBT or Dynamic or Supportive Psychotherapy for Recurrent Major Depression
Sponsor:
Sir Mortimer B Davis - Jewish General Hospital
Organization:
Sir Mortimer B Davis - Jewish General Hospital
Study Overview
Official Title:
Efficacy and Cost-Effectiveness of 18-Months of Antidepressive Medication Plus Either Cognitive-Behavior Therapy or Dynamic Psychotherapy Compared to Supportive Clinical Management for Recurrent Major Depression a Pilot Study
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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:
Major Depressive Disorder affects approximately 16 of the adult population over the lifetime Controlled studies indicate that short-term antidepressive medications or psychotherapy produce full remission in only about 46 of patients Furthermore about 80 of patients will continue to have subsequent recurrences after remission of the first episode with each episode increasing the probability of future recurrences This pilot study will examine whether antidepressive medications plus one of three commonly available types of psychotherapy used in the short-term treatment of depression can protect against the recurrence of depression if active treatment is extended to 18-months duration Results will aid designing a more complete study
Adults with an acute episode of major depressive disorder with at least one prior episode will be randomized to Antidepressive medications ADM plus 18-months of either Cognitive-behavioral therapy CBT or Dynamic psychotherapy DYN or to a standard control therapy Supportive Clinical Management SUP-CM We will determine whether a higher percentage of those receiving either CBT or DYN remain well after three years of follow-up compared to those receiving the standard control treatment We will also examine the reduction in psychological risk factors as well as potential economic benefits of the three approaches
Adults with an acute episode of major depressive disorder with at least one prior episode will be randomized to Antidepressive medications ADM plus 18-months of either Cognitive-behavioral therapy CBT or Dynamic psychotherapy DYN or to a standard control therapy Supportive Clinical Management SUP-CM We will determine whether a higher percentage of those receiving either CBT or DYN remain well after three years of follow-up compared to those receiving the standard control treatment We will also examine the reduction in psychological risk factors as well as potential economic benefits of the three approaches
Detailed Description:
Major Depressive Disorder affects approximately 15 of the adult population over a lifetime Controlled studies indicate that short-term antidepressive medications or psychotherapy produce full remission in only about 46 of patients Furthermore about 80 of patients will continue to have subsequent recurrences after remission of the first episode with each episode increasing the probability of future recurrences The World Health Organization estimates that by the year 2020 depression will be the second largest cause of medical disability worldwide As a result there is a need to validate treatments that produce remission and prevent recurrences upon long-term follow-up Furthermore since several treatment types are currently widely practiced there is a need to demonstrate both their efficacies and cost effectiveness
We propose to conduct a pilot study to determine the feasibility and provide estimates for a randomized controlled study of combined antidepressive medications plus one of three forms of psychotherapy in common use for adults with an acute episode of recurrent major depression Two treatments of interest Cognitive-behavioural CBT and psychodynamic DYN psychotherpy will be compared to Supportive Clinical Management SUP-CM which will serve as the control Overall the study will compare each active psychotherapy to the control treatment for retention-attrition and efficacy in producing remission preventing recurrence after up to 18-months of treatment and improving functioning Secondary aims will explore whether putative psychological risk factors for depression improve more in the active psychotherapies than in the control condition and determine whether this improvement predicts or mediates staying well Finally we will develop preliminary estimates of the cost-effectiveness and cost-offset of the three treatment conditions at termination and 3 year post-treatment follow-up If either or both active treatments give estimates of superior prevention of recurrences or residual symptoms and impairment these estimates will be used to plan a subsequent more definitive study including their relative cost-effectiveness and cost-offset
Adults N30 10 per condition meeting DSM-IV-TR criteria for an acute episode of major depressive disorder with at least one prior episode will be randomized to 18-months of either 1 Cognitive-behavioral therapy CBT or 2 Psychodynamic psychotherapy DYN to a standard control treatment 3 Supportive Clinical Management All patients will receive antidepressive medications ADM which will be prescribed according to a pre-defined protocol similar to the CANMAT guidelines Once remission has been achieved continuation of ADM will follow the same guidelines in all three therapy conditions Assessments will include the LIFE-method to code the course of depressive episodes and dysthymia the HRSD-17 and BDI-2 role functioning and impulse symptom measures and theoretically based measures of both cognitive affective and dynamic psychological risk factors and health care costs and economic productivity Patients will be assessed at intake and six month intervals for the treatment period and three year subsequent follow-up totaling up to 54 months for each patient The HRSD-17 and economic data will be collected more frequently Intent-to-treat analyses will compare each active treatment to the control treatment If 18-months of either of these two most commonly used psychotherapies provides estimates of reduced recurrence and morbidity compared to standard treatment these estimates will be used to design and power a subsequent complete study including cost-effectiveness and cost-offset
We propose to conduct a pilot study to determine the feasibility and provide estimates for a randomized controlled study of combined antidepressive medications plus one of three forms of psychotherapy in common use for adults with an acute episode of recurrent major depression Two treatments of interest Cognitive-behavioural CBT and psychodynamic DYN psychotherpy will be compared to Supportive Clinical Management SUP-CM which will serve as the control Overall the study will compare each active psychotherapy to the control treatment for retention-attrition and efficacy in producing remission preventing recurrence after up to 18-months of treatment and improving functioning Secondary aims will explore whether putative psychological risk factors for depression improve more in the active psychotherapies than in the control condition and determine whether this improvement predicts or mediates staying well Finally we will develop preliminary estimates of the cost-effectiveness and cost-offset of the three treatment conditions at termination and 3 year post-treatment follow-up If either or both active treatments give estimates of superior prevention of recurrences or residual symptoms and impairment these estimates will be used to plan a subsequent more definitive study including their relative cost-effectiveness and cost-offset
Adults N30 10 per condition meeting DSM-IV-TR criteria for an acute episode of major depressive disorder with at least one prior episode will be randomized to 18-months of either 1 Cognitive-behavioral therapy CBT or 2 Psychodynamic psychotherapy DYN to a standard control treatment 3 Supportive Clinical Management All patients will receive antidepressive medications ADM which will be prescribed according to a pre-defined protocol similar to the CANMAT guidelines Once remission has been achieved continuation of ADM will follow the same guidelines in all three therapy conditions Assessments will include the LIFE-method to code the course of depressive episodes and dysthymia the HRSD-17 and BDI-2 role functioning and impulse symptom measures and theoretically based measures of both cognitive affective and dynamic psychological risk factors and health care costs and economic productivity Patients will be assessed at intake and six month intervals for the treatment period and three year subsequent follow-up totaling up to 54 months for each patient The HRSD-17 and economic data will be collected more frequently Intent-to-treat analyses will compare each active treatment to the control treatment If 18-months of either of these two most commonly used psychotherapies provides estimates of reduced recurrence and morbidity compared to standard treatment these estimates will be used to design and power a subsequent complete study including cost-effectiveness and cost-offset
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