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Cognitive and Drug Therapy for Drug-Resistant Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000376
First Posted: November 3, 1999
Last Update Posted: October 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose

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.


Condition Intervention
Depression Anxiety Disorders Personality Disorders Drug-resistant Depression Behavioral: Cognitive therapy Drug: Desipramine

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Study Start Date: March 1996
Estimated Study Completion Date: February 1999
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

Patients must have:

Drug-resistant depression (DRD).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000376


Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Karla Moras, PhD
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00000376     History of Changes
Other Study ID Numbers: R21MH052737 ( U.S. NIH Grant/Contract )
DSIR
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: October 12, 2015
Last Verified: December 2005

Keywords provided by University of Pennsylvania:
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

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Anxiety Disorders
Personality Disorders
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Desipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs