Cognitive and Drug Therapy for Drug-Resistant Depression

NCT00000376 | Completed

• 2 other identifiers: R21MH052737DSIR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Interventions

Cognitive therapy BEHAVIORAL

Desipramine DRUG

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Depression; Anxiety Disorders; Personality Disorders

Interventions

Cognitive Behavioral Therapy; Desipramine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Karla Moras, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Start: March 1, 1996
• Study Completion: February 1, 1999
• Last Updated: October 12, 2015

Record last verified: 2005-12