Postpartum Depression
Conditions
Keywords
women, postpartum depression, anxiety
Brief summary
The purpose of this study is to determine whether women with postpartum major depressive disorder (MDD) will experience a significant decrease in depressive symptoms from baseline over an eight-week treatment intervention with escitalopram (Lexapro). Also, to determine whether women with postpartum MDD will experience a significant decrease in anxiety symptoms.
Interventions
DRUGEscitalopram
Once daily by mouth
Sponsors
Forest Laboratories
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women ages 18 to 45 years old * Subjects must meet criteria for a major depressive episode with symptoms developing within three month of live childbirth * Subjects must present within six months of childbirth * MADRS score \>15 * BAI score \>10 * Subjects will be able to be treated on an outpatient basis * Subjects will be able to provide written informed consent
Exclusion criteria
* Subjects who have taken any psychotropic medication, including antidepressants and anti-anxiety medication, within the past two weeks (with the exception of non-benzodiazepine medications used for sleep, including trazodone, zolpidem, eszopiclone, etc) * Suicidal ideation with active plan or intent, as determined by the investigator * Presence of psychotic symptoms or homicidal ideation * History of mania or hypomania * Pregnant or breastfeeding * Presence of chronic depression or dysthymia, or chronic or treatment resistant anxiety disorders, as determined by investigator * Active alcohol/substance abuse currently or within the past year * Abnormal TSH, severe anemia, or uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) | 8 weeks | The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Edinburgh Postnatal Depression Scale (EPDS) | 8 weeks | The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of \>9 is indicative of perinatal major depression. |
| Change in Beck Anxiety Inventory (BAI) | 8 weeks | Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety). |
Countries
United States
Participant flow
Pre-assignment details
Seven subjects were enrolled in this study. Prior to receiving treatment, two subjects were found to be ineligible per protocol eligibility requirements.
Participants by arm
| Arm | Count |
|---|---|
| Escitalopram Flexible dose escitalopram 10mg
Escitalopram: Once daily by mouth | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Escitalopram |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).
Time frame: 8 weeks
Population: Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) | -21.33 units on a scale | Standard Deviation 11.24 |
Secondary
Change in Beck Anxiety Inventory (BAI)
Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety).
Time frame: 8 weeks
Population: Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Change in Beck Anxiety Inventory (BAI) | -15.00 units on a scale | Standard Deviation 9.85 |
Secondary
Change in Edinburgh Postnatal Depression Scale (EPDS)
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of \>9 is indicative of perinatal major depression.
Time frame: 8 weeks
Population: Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Change in Edinburgh Postnatal Depression Scale (EPDS) | -19.33 units on a scale | Standard Deviation 2.52 |