search
Back to results

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
University of Pennsylvania
About
Eligibility
Locations
Outcomes
Full info

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

21 Years - 60 Years (Adult)All Sexes

Inclusion Criteria: - Patients must have: Drug-resistant depression (DRD).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 1999
    Last Updated
    October 9, 2015
    Sponsor
    University of Pennsylvania
    Collaborators
    National Institute of Mental Health (NIMH)
    search

    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

    We'll reach out to this number within 24 hrs