Completed

Cognitive and Drug Therapy for Drug-Resistant Depression

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What is being tested

Cognitive therapy

+ Desipramine

BehavioralDrug
Who is being recruted

Behavior+3

+ Mental Disorders

+ Behavioral Symptoms

From 21 to 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 1996
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: October 12, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00000376
Principal SponsorUniversity of Pennsylvania
Last updated: October 12, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 60 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsAnxiety DisordersDepressionPersonality Disorders

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers