Depression, PostpartumPhase 2NCT00602355
Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression
A Phase 2 study testing Sertraline, Interpersonal psychotherapy (IPT) and Clinical management in people with Depression, Postpartum, run by Women and Infants Hospital of Rhode Island at 2 sites in United States.
Trial summary
This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Sertraline, Interpersonal psychotherapy (IPT) and Clinical management
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primary DSM-IV diagnosis of major depressive disorder by clinical interview
- Score of greater than 12 on HAM-D
- Delivery of an infant within the 12 months prior to study entry
- Able to speak and read English sufficiently to complete the study procedures
- Willing to use effective birth control methods throughout the study
Who cannot join
- Woman whose infant has died prior to study entry
- Current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder;
- Diagnosis of alcohol or drug abuse or dependence (except nicotine) or anorexia in the past year;
- Psychotic symptoms;
- Acute suicidal or homicidal risks;
- Women who have been on an antidepressant for more than 14 days prior to consent, (if less than 14 days and willing to taper off, will be eligible to continue once tapered off);
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- Women on daily anxiolytic medication (i.e. benzodiazepine, buspirone) or daily psychoactive herbal preparation (St. John's Wort or Fish Oil) (if willing to discontinue these substances may be eligible once they have been tapered off);
- Medications taken PRN over the listed dose and frequency (women will still be eligible if they take: Lunesta/Eszopiclone 3 mg or less, up to 3 nights a week, Ambien/Zolpidem 5mg or less, Ambien CR 6.25 mg or less, up to 3 nights a week, Lorazepam or equivalent benzodiazepine dose: 0.5 mg up to 3 nights a week, Sonata/Zaleplon: 5 mg or less, up to 3 nights a week, Rozerem/Ramelteon: 8 mg or less, up to 3 nights a week);
- If they take antidepressants PRN for insomnia (eg: Desyrel/Trazodone, Elavil/Amitriptyline, Remeron/Mirtazapine;
- Ongoing concurrent psychotherapeutic treatment or psychotherapeutic treatment within the last month;
- Psychiatric symptoms requiring specialized psychiatric treatment;
- Significant medical disorder that would make sertraline treatment contra-indicated,
- Previous trial of IPT therapy with a certified IPT therapist or an adequate trial of sertraline (i.e. at least 8 weeks of at least 100 mg daily of sertraline).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa
Iowa City, Iowa, 52242
Women and Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: Placebo Controlled Trial of Sertraline and Interpersonal Psycho-Therapy for Postpartum Depression
This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression.
Read the detailed description
Postpartum depression (PPD) occurs in approximately 13% of postpartum women. The impact of PPD is significant, including emotional distress for the woman as well as disturbances in infant development. Common signs of depression after childbirth may include anxiety, irritability, low energy, and lack of concern for self or infant. If left untreated, PPD may last for more than 1 year, causing strain on family life and the mother's relationship with her infant. Infants of depressed mothers are also at a higher risk for developmental delays, behavioral problems, and difficulty eating and sleeping. Despite the public health significance of PPD, relatively little research has been done to determine the most effective treatments. Specifically, there is a lack of research concerning the use of antidepressant medication for treating PPD. Interpersonal psychotherapy (IPT), which focuses on interpersonal issues related to depression, has been more thoroughly studied for the treatment for PPD, but it has not been compared to the other treatment. This study will evaluate the effectiveness of antidepressant medication alone and IPT alone in treating women with PPD.
Participation in this double-blind study will last 9 months. Participants will first undergo initial assessments, which include interviews about depressive symptoms, self-report forms about medical history, blood tests, and a pregnancy test. Participants will then be randomly assigned to one of three treatments: sertraline, placebo, or IPT. All three treatments will be administered over 13 weeks. Participants assigned to take sertraline or placebo will attend nine 30-minute sessions over the 13-week treatment period. During these sessions, participants will be administered the study medication and will be assisted with parenting issues and skills by a psychiatrist. Participants receiving IPT will attend weekly 50-minute sessions over the 13-week treatment period. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. All participants will also complete interviews and questionnaires about their depression once a month. Following the 13 weeks of treatment, participants will undergo follow-up assessments at Months 3 and 6 post-treatment. Follow-up assessments will repeat initial interviews and questionnaires and will include a form about the infant's nature.
- Conditions
- Depression, Postpartum
- Being tested
- Sertraline, Placebo, Interpersonal psychotherapy (IPT), Clinical management, Mothercrafting
- Keywords
- Postpartum, Depression, Medication Therapy, Zoloft, Sertraline, Interpersonal Psychotherapy
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific "mother-crafting" techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
PlaceboDrug
Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific "mother-crafting" techniques as those taking sertraline.
Interpersonal psychotherapy (IPT)Behavioural
IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills.
Clinical managementBehavioural
Clinical management includes treatment as usual for those receiving medication for depression.
MothercraftingBehavioural
Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care
| Study group | Role | What they receive |
|---|---|---|
| 1 (Placebo) | Placebo comparator | Participants receiving placebo pill with clinical management plus mothercrafting Receives: Drug: Placebo; Behavioral: Clinical management; Behavioral: Mothercrafting |
| 2 (Sertraline) | Active comparator | Participants receiving active medication sertraline with clinical management plus mothercrafting Receives: Drug: Sertraline; Behavioral: Clinical management; Behavioral: Mothercrafting |
| 3 (IPT) | Active comparator | Participants receiving interpersonal psychotherapy (IPT) alone Receives: Behavioral: Interpersonal psychotherapy (IPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-D)
Measure total ranges from 0 to 50, with lower scores indicating better outcomes.
Measured: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Secondary outcomes (4)
Depression Illness Severity Based on Beck Depression Inventory (BDI)
Measure total ranges from 0 to 56, with lower scores indicating better outcomes.
Measured: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Global Illness Severity Based on Clinical Global Impression (CGI) Scale
Measure total ranges from 1 to 7, with lower scores indicating better outcomes.
Measured: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)
Measure total ranges from 1 to 5, with lower scores indicating better outcomes.
Measured: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Hamilton Anxiety Rating Scale (HARS)
Measure total ranges from 0 to 56, with lower scores indicating better outcomes.
Measured: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Caron Zlotnick, Women and Infants Hospital of Rhode Island
- Investigators
- Caron Zlotnick, Principal investigator, Women and Infants HospitalScott Stuart, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602355
- Sponsor's protocol ID
- R01MH074919
- Other IDs
- R01MH074919, R01MH074636, DSIR 83-ATP
- Status last verified
- Jul 2016
- First submitted
- 23 Jan 2008
- Last updated
- 21 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
O'Hara MW, Pearlstein T, Stuart S, Long JD, Mills JA, Zlotnick C. A placebo controlled treatment trial of sertraline and interpersonal psychotherapy for postpartum depression. J Affect Disord. 2019 Feb 15;245:524-532. doi: 10.1016/j.jad.2018.10.361. Epub 2018 Oct 31.
PubMed 30447565
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Trial of Sertraline and Interpersonal Psycho-Therapy for Postpartum Depression
- ClinicalTrials.gov ID
- NCT00602355
- Acronym / sponsor ID
- R01MH074919
- Conditions
- Depression, Postpartum
- Keywords
- Postpartum, Depression, Medication Therapy, Zoloft, Sertraline, Interpersonal Psychotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Posted 21 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression.
Detailed description
Postpartum depression (PPD) occurs in approximately 13% of postpartum women. The impact of PPD is significant, including emotional distress for the woman as well as disturbances in infant development. Common signs of depression after childbirth may include anxiety, irritability, low energy, and lack of concern for self or infant. If left untreated, PPD may last for more than 1 year, causing strain on family life and the mother's relationship with her infant. Infants of depressed mothers are also at a higher risk for developmental delays, behavioral problems, and difficulty eating and sleeping. Despite the public health significance of PPD, relatively little research has been done to determine the most effective treatments. Specifically, there is a lack of research concerning the use of antidepressant medication for treating PPD. Interpersonal psychotherapy (IPT), which focuses on interpersonal issues related to depression, has been more thoroughly studied for the treatment for PPD, but it has not been compared to the other treatment. This study will evaluate the effectiveness of antidepressant medication alone and IPT alone in treating women with PPD.
Participation in this double-blind study will last 9 months. Participants will first undergo initial assessments, which include interviews about depressive symptoms, self-report forms about medical history, blood tests, and a pregnancy test. Participants will then be randomly assigned to one of three treatments: sertraline, placebo, or IPT. All three treatments will be administered over 13 weeks. Participants assigned to take sertraline or placebo will attend nine 30-minute sessions over the 13-week treatment period. During these sessions, participants will be administered the study medication and will be assisted with parenting issues and skills by a psychiatrist. Participants receiving IPT will attend weekly 50-minute sessions over the 13-week treatment period. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. All participants will also complete interviews and questionnaires about their depression once a month. Following the 13 weeks of treatment, participants will undergo follow-up assessments at Months 3 and 6 post-treatment. Follow-up assessments will repeat initial interviews and questionnaires and will include a form about the infant's nature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 (Placebo) | Placebo comparator | Drug: Placebo, Behavioral: Clinical management, Behavioral: MothercraftingParticipants receiving placebo pill with clinical management plus mothercrafting |
| 2 (Sertraline) | Active comparator | Drug: Sertraline, Behavioral: Clinical management, Behavioral: MothercraftingParticipants receiving active medication sertraline with clinical management plus mothercrafting |
| 3 (IPT) | Active comparator | Behavioral: Interpersonal psychotherapy (IPT)Participants receiving interpersonal psychotherapy (IPT) alone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primary DSM-IV diagnosis of major depressive disorder by clinical interview
- Score of greater than 12 on HAM-D
- Delivery of an infant within the 12 months prior to study entry
- Able to speak and read English sufficiently to complete the study procedures
- Willing to use effective birth control methods throughout the study
Key exclusion criteria (13 listed)
- Woman whose infant has died prior to study entry
- Current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder;
- Diagnosis of alcohol or drug abuse or dependence (except nicotine) or anorexia in the past year;
- Psychotic symptoms;
- Acute suicidal or homicidal risks;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineAlso: ZoloftParticipants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific "mother-crafting" techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care. | Drug | 2 (Sertraline) |
| PlaceboParticipants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific "mother-crafting" techniques as those taking sertraline. | Drug | 1 (Placebo) |
| Interpersonal psychotherapy (IPT)IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. | Behavioural | 3 (IPT) |
| Clinical managementClinical management includes treatment as usual for those receiving medication for depression. | Behavioural | 1 (Placebo), 2 (Sertraline) |
| MothercraftingMother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care | Behavioural | 1 (Placebo), 2 (Sertraline) |
Primary outcome
Hamilton Depression Rating Scale (HAM-D)
Time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Measure total ranges from 0 to 50, with lower scores indicating better outcomes.
4 secondary outcomes
Depression Illness Severity Based on Beck Depression Inventory (BDI)
Time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Global Illness Severity Based on Clinical Global Impression (CGI) Scale
Time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)
Time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Hamilton Anxiety Rating Scale (HARS)
Time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30447565O'Hara MW, Pearlstein T, Stuart S, Long JD, Mills JA, Zlotnick C. A placebo controlled treatment trial of sertraline and interpersonal psychotherapy for postpartum depression. J Affect Disord. 2019 Feb 15;245:524-532. doi: 10.1016/j.jad.2018.10.361. Epub 2018 Oct 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caron Zlotnick principal investigator
Women and Infants Hospital
Scott Stuart, MD principal investigator
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sertraline, Interpersonal psychotherapy (IPT) and Clinical management in people with Depression, Postpartum, run by Women and Infants Hospital of Rhode Island at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HAM-D) (time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00602355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.