Depression
Conditions
Keywords
Elderly, Remission, Escitalopram, Interpersonal Psychotherapy, Psychotherapy, Caregiving, Late-Life
Brief summary
This study will determine whether adding interpersonal psychotherapy to treatment with the antidepressant escitalopram will be more effective in reducing symptoms of depression than antidepressant medication alone.
Detailed description
The purpose of this research study is to learn if adding psychotherapy (Interpersonal Psychotherapy) to antidepressant medication (escitalopram), will be more effective in reducing lingering symptoms of depression and decreasing the burden of these symptoms, when initial treatment with just antidepressant medication alone has led to only a partial response. Participation in the study will last up to 22 weeks. Because fewer than 50% of elderly depressed patients achieve remission and recovery in response to first-line antidepressant pharmacotherapy, the majority of patients are left with significant symptoms and functional impairment, putting them at risk of chronic, relapsing illness, non-adherence to other medical treatment, suicide, and family caregiver burden. We will recruit and treat 320 patients with unipolar major depression aged 60 and older, using clinical management with escitalopram 10 mg/day for six weeks. Patients who are partial responders to escitalopram plus clinical management will be randomly assigned to 16 weeks of extension therapy with either 20 mg escitalopram plus clinical management or 20 mg escitalopram plus Interpersonal Psychotherapy (IPT, 16 sessions). Changes over time in measures of depressive symptoms, hopelessness, suicidal ideation, disability, and family caregiving burden will be assessed. This study will answer the question of how best to treat partial responders-by simply extending pharmacotherapy at higher doses, or by also adding psychotherapy-to remission and recovery. For information on related studies, please follow these links: http://clinicaltrials.gov/show/NCT00178035 http://clinicaltrials.gov/show/NCT00178074
Interventions
DRUGEscitalopram
Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.
BEHAVIORALInterpersonal Psychotherapy
16 sessions of interpersonal psychotherapy (IPT)
BEHAVIORALClinical Monitoring
16 weeks of depression care management(DCM). No psychotherapy will be provided.
Sponsors
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of unipolar major depression * Hamilton Rating Scale for Depression (HRSD) (17 item) score of 15 or higher * Speaks English * Willing to discontinue other psychotropic medications * Availability of family member or other caregiver * Hearing capacity adequate to respond to a raised conversational voice
Exclusion criteria
* Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or any psychotic disorder * Folstein Mini-Mental Status Exam (MMSE) of 17 or lower * Suicidal * History of treatment non-adherence in other Center protocols * History of documented non-response to citalopram in other Center protocols * History of non-tolerance to escitalopram therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission | Measured at Week 6 or 22 | Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from primary care and specialty mental-health clinics. 377 participants signed consent; 319 started study treatment; 124 were randomized. Of the 124 participants, 60 were randomized to Interpersonal Psychotherapy (IPT) and 59 randomized to Depression Care Management(DCM) without IPT.
Pre-assignment details
67 enrolled participants were not randomized due to the following reasons: consent withdrawal (41); did not meet eligibility criteria (16); supervening medical problems that precluded participation (4); past history of non-reponse to escitalopram (1); side effects (1).
Participants by arm
| Arm | Count |
|---|---|
| Escitalopram Plus Interpersonal Psychotherapy (IPT) Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT) | 60 |
| Escitalopram Plus Depression Care Management (DCM) Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT) | 64 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 7 | 5 |
Baseline characteristics
| Characteristic | Escitalopram Plus Depression Care Management (DCM) | Escitalopram Plus Interpersonal Psychotherapy (IPT) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 55 Participants | 49 Participants | 104 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 11 Participants | 20 Participants |
| Age Continuous | 73.4 years STANDARD_DEVIATION 7.7 | 71.1 years STANDARD_DEVIATION 7.1 | 72.27 years STANDARD_DEVIATION 7.51 |
| Region of Enrollment United States | 64 participants | 60 participants | 124 participants |
| Sex: Female, Male Female | 41 Participants | 44 Participants | 85 Participants |
| Sex: Female, Male Male | 23 Participants | 16 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 64 |
| serious Total, serious adverse events | 0 / 60 | 0 / 64 |
Outcome results
Primary
Remission
Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression.
Time frame: Measured at Week 6 or 22
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Escitalopram Plus Interpersonal Psychotherapy (IPT) | Remission | 58 Percentage of participants |
| Escitalopram Plus Depression Care Management (DCM) | Remission | 45 Percentage of participants |
Comparison: We conducted Cox regreassion analyses of time to remission and logistic modeling for rates of remission. We tested group difference in Hamilton depession ratings over time via mixed-effects modeling.p-value: 0.14Regression, Logistic