Depression Clinical Trial
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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