Cognitive and Drug Therapy for Drug-Resistant Depression
Primary Purpose
Depression, Anxiety Disorders, Personality Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive therapy
Desipramine
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Adult, Antidepressive Agents, Tricyclic, Anxiety Disorders, Cognitive Therapy, Combined Modality Therapy, Depression, Desipramine, Female, Human, Male, Personality Disorders, Pilot Projects, Patient Care Team, Antidepressive Agents, Tricyclic -- *therapeutic use, Depression -- *therapy, Depression -- drug therapy, Desipramine -- *therapeutic use
Eligibility Criteria
Inclusion Criteria: - Patients must have: Drug-resistant depression (DRD).
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000376
First Posted
November 2, 1999
Last Updated
October 9, 2015
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00000376
Brief Title
Cognitive and Drug Therapy for Drug-Resistant Depression
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
March 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1999 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
To develop an effective combined cognitive therapy (CT) plus drug treatment for patients with drug-resistant depression (DRD) (i.e., 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.
Detailed Description
To develop an effective combined cognitive therapy (CT) plus drug treatment for patients with drug-resistant depression (DRD) (i.e., 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety Disorders, Personality Disorders, Drug-resistant Depression
Keywords
Adult, Antidepressive Agents, Tricyclic, Anxiety Disorders, Cognitive Therapy, Combined Modality Therapy, Depression, Desipramine, Female, Human, Male, Personality Disorders, Pilot Projects, Patient Care Team, Antidepressive Agents, Tricyclic -- *therapeutic use, Depression -- *therapy, Depression -- drug therapy, Desipramine -- *therapeutic use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive therapy
Intervention Type
Drug
Intervention Name(s)
Desipramine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Eligibility Criteria
Inclusion Criteria:
-
Patients must have:
Drug-resistant depression (DRD).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karla Moras, PhD
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Cognitive and Drug Therapy for Drug-Resistant Depression
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