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Cognitive and Drug Therapy for Drug-Resistant Depression
This study has been completed.
Study NCT00000376   Information provided by National Institute of Mental Health (NIMH)
First Received: November 2, 1999   Last Updated: December 6, 2005   History of Changes

November 2, 1999
December 6, 2005
March 1996
 
 
 
Complete list of historical versions of study NCT00000376 on ClinicalTrials.gov Archive Site
 
 
 
Cognitive and Drug Therapy for Drug-Resistant Depression
 

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.

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.

 
Interventional
Treatment, Randomized
  • Depression
  • Anxiety Disorders
  • Personality Disorders
  • Drug-Resistant Depression
  • Behavioral: Cognitive therapy
  • Drug: Desipramine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
February 1999
 

Inclusion Criteria:

-

Patients must have:

Drug-resistant depression (DRD).

Both
21 Years to 60 Years
 
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00000376
 
MH52737, DSIR
National Institute of Mental Health (NIMH)
 
Principal Investigator: Karla Moras, PhD
National Institute of Mental Health (NIMH)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP