Postpartum DepressionNCT01028482
Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline
A study testing Sertraline and psychotherapy in people with Postpartum Depression, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Introduction: Postpartum depression (PPD) occurs in large numbers of women (between 10 - 20%) and substantially affects both their own well-being and their offspring's mental and emotional development. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Sertraline and psychotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18- 45 y.o.
- SCID-DSM-IV diagnosis of major depression, mild to moderate severity
- Understanding of Hebrew
- Willing to sign the informed consent
- Lactating women will be included after a thorough explanation of current knowledge of sertraline and lactation.
Who cannot join
- Severe major depression (MADRS > 30)
- Suicidal ideation (MADRS item 10 score of > 5)
- Psychotic symptoms or aggressive thoughts toward the baby.
- Current treatment with antidepressant medication
- Physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.)
- Alcoholism or drug abuse and dependence
- Bipolar Disorder
- Past severe side effects to SSRIs
Trial locations and contacts
1 site in 1 country.
About this study
Introduction:
Postpartum depression (PPD) occurs in large numbers of women (between 10 - 20%) and substantially affects both their own well-being and their offspring's mental and emotional development. Whereas PPD is a form of major depression, its etiology is probably related to a combination of biological (hereditary, hormonal etc.), and psychological factors. In practice, most women suffering from PPD do not seek treatment, or are treated with psychotherapy alone due to concerns regarding pharmacotherapy. This is despite the obvious importance of reaching a rapid remission in these women. In fact, data regarding the treatment of PPD with antidepressants is surprisingly sparse and is limited to only one blinded and placebo-controlled study (with fluoxetine) and a number of studies without a placebo arm . The reason for the paucity of double-blinded placebo-controlled studies is probably due to 3 main limiting factors: Firstly, the reluctance of women to "admit" to and seek professional help due to depression, Secondly, the difficulty to administer antidepressant medication to lactating women, and, Thirdly, the ethical difficulties in designing a study with a real placebo group.
Read more
In contrast to the very limited number of drug studies in this population, there are a number of studies that have shown the efficacy of psychotherapy in the treatment of PPD. Positive studies have been published using different types of psychotherapy, including cognitive, dynamic and interpersonal psychotherapy.
The investigators propose to study the efficacy of psychotherapeutic treatment in women suffering from PPD with add-on sertraline in a randomized double-blind, placebo-controlled design. To overcome the difficulties described above in studying antidepressants in the postpartum period, the investigators propose to include active brief dynamic psychotherapy for all women. Furthermore, the investigators will selectively allow inclusion of women who only suffer from either mild or moderate major PPD (not severe / suicidal) .
Hypothesis:
The investigators hypothesize that women with PPD randomized to the arm receiving psychotherapy + active sertraline will show a greater response rate than the psychotherapy + placebo group. Furthermore, the investigators hypothesize that the difference in response between the 2 groups will demonstrate a significant early response in the active sertraline group.
- Conditions
- Postpartum Depression
- Being tested
- Sertraline, placebo, psychotherapy
- Keywords
- severity of depression measured by MADRS and CGI
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
group A- sertraline 50-100 mg/day and weekly psychotherapy for 3 months
group B- weekly psychotherapy- for 3 months
group C- sertraline 50-100 mg/day-for 3 months
placeboDrug
placebo
psychotherapyOther
psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| sertraline, psychotherapy | Experimental | both study groups will receive concomitant psychotherapy treatment. There will be 2 main comparison groups: 1) an sertraline treated group and 2) a drug placebo - controlled group. While this design lacks a blinded "drug-only" condition, we will have an "open" drug-only arm that will be of considerable value. Furthermore, while a true placebo group is also lacking, and a certain response to psychotherapy is expected, we believe that the drug condition will show a definite superiority to the psychotherapy + placebo condition. The rational for including psychotherapy in the treatment protocol is the fact that this is a well-established treatment for PPD, and for ethical considerations it is unreasonable not to administer any active treatment to women suffering from PPD. It is our conviction that this is the only design, albeit its limitations, which will allow a comparison between medication-treated vs. placebo-treated PPD patients. Receives: Drug: Sertraline; Other: psychotherapy |
| placebo, psychotherapy | Placebo comparator | both study groups will receive concomitant psychotherapy treatment. There will be 2 main comparison groups: 1) an sertraline treated group and 2) a drug placebo - controlled group. While this design lacks a blinded "drug-only" condition, we will have an "open" drug-only arm that will be of considerable value. Furthermore, while a true placebo group is also lacking, and a certain response to psychotherapy is expected, we believe that the drug condition will show a definite superiority to the psychotherapy + placebo condition. The rational for including psychotherapy in the treatment protocol is the fact that this is a well-established treatment for PPD, and for ethical considerations it is unreasonable not to administer any active treatment to women suffering from PPD. It is our conviction that this is the only design, albeit its limitations, which will allow a comparison between medication-treated vs. placebo-treated PPD patients. Receives: Drug: placebo; Other: psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startMar 2008
- Primary completionNov 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028482
- Sponsor's protocol ID
- TASMC-09-MB-301-CTIL
- Status last verified
- May 2011
- First submitted
- 3 Jun 2009
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bloch M, Meiboom H, Lorberblatt M, Bluvstein I, Aharonov I, Schreiber S. The effect of sertraline add-on to brief dynamic psychotherapy for the treatment of postpartum depression: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012 Feb;73(2):235-41. doi: 10.4088/JCP.11m07117.
PubMed 22401479
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline
- ClinicalTrials.gov ID
- NCT01028482
- Acronym / sponsor ID
- TASMC-09-MB-301-CTIL
- Conditions
- Postpartum Depression
- Keywords
- severity of depression measured by MADRS and CGI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction:
Postpartum depression (PPD) occurs in large numbers of women (between 10 - 20%) and substantially affects both their own well-being and their offspring's mental and emotional development. Whereas PPD is a form of major depression, its etiology is probably related to a combination of biological (hereditary, hormonal etc.), and psychological factors. In practice, most women suffering from PPD do not seek treatment, or are treated with psychotherapy alone due to concerns regarding pharmacotherapy. This is despite the obvious importance of reaching a rapid remission in these women. In fact, data regarding the treatment of PPD with antidepressants is surprisingly sparse and is limited to only one blinded and placebo-controlled study (with fluoxetine) and a number of studies without a placebo arm . The reason for the paucity of double-blinded placebo-controlled studies is probably due to 3 main limiting factors: Firstly, the reluctance of women to "admit" to and seek professional help due to depression, Secondly, the difficulty to administer antidepressant medication to lactating women, and, Thirdly, the ethical difficulties in designing a study with a real placebo group.
In contrast to the very limited number of drug studies in this population, there are a number of studies that have shown the efficacy of psychotherapy in the treatment of PPD. Positive studies have been published using different types of psychotherapy, including cognitive, dynamic and interpersonal psychotherapy.
The investigators propose to study the efficacy of psychotherapeutic treatment in women suffering from PPD with add-on sertraline in a randomized double-blind, placebo-controlled design. To overcome the difficulties described above in studying antidepressants in the postpartum period, the investigators propose to include active brief dynamic psychotherapy for all women. Furthermore, the investigators will selectively allow inclusion of women who only suffer from either mild or moderate major PPD (not severe / suicidal) .
Hypothesis:
The investigators hypothesize that women with PPD randomized to the arm receiving psychotherapy + active sertraline will show a greater response rate than the psychotherapy + placebo group. Furthermore, the investigators hypothesize that the difference in response between the 2 groups will demonstrate a significant early response in the active sertraline group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sertraline, psychotherapy | Experimental | Drug: Sertraline, Other: psychotherapyboth study groups will receive concomitant psychotherapy treatment. There will be 2 main comparison groups: 1) an sertraline treated group and 2) a drug placebo - controlled group. While this design lacks a blinded "drug-only" condition, we will have an "open" drug-only arm that will be of considerable value. Furthermore, while a true placebo group is also lacking, and a certain response to psychotherapy is expected, we believe that the drug condition will show a definite superiority to the psychotherapy + placebo condition. The rational for including psychotherapy in the treatment protocol is the fact that this is a well-established treatment for PPD, and for ethical considerations it is unreasonable not to administer any active treatment to women suffering from PPD. It is our conviction that this is the only design, albeit its limitations, which will allow a comparison between medication-treated vs. placebo-treated PPD patients. |
| placebo, psychotherapy | Placebo comparator | Drug: placebo, Other: psychotherapyboth study groups will receive concomitant psychotherapy treatment. There will be 2 main comparison groups: 1) an sertraline treated group and 2) a drug placebo - controlled group. While this design lacks a blinded "drug-only" condition, we will have an "open" drug-only arm that will be of considerable value. Furthermore, while a true placebo group is also lacking, and a certain response to psychotherapy is expected, we believe that the drug condition will show a definite superiority to the psychotherapy + placebo condition. The rational for including psychotherapy in the treatment protocol is the fact that this is a well-established treatment for PPD, and for ethical considerations it is unreasonable not to administer any active treatment to women suffering from PPD. It is our conviction that this is the only design, albeit its limitations, which will allow a comparison between medication-treated vs. placebo-treated PPD patients. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women 18- 45 y.o.
- SCID-DSM-IV diagnosis of major depression, mild to moderate severity
- Understanding of Hebrew
- Willing to sign the informed consent
- Lactating women will be included after a thorough explanation of current knowledge of sertraline and lactation.
Key exclusion criteria (8 listed)
- Severe major depression (MADRS > 30)
- Suicidal ideation (MADRS item 10 score of > 5)
- Psychotic symptoms or aggressive thoughts toward the baby.
- Current treatment with antidepressant medication
- Physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.)
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 |
|---|---|---|
| Sertralinegroup A- sertraline 50-100 mg/day and weekly psychotherapy for 3 months group B- weekly psychotherapy- for 3 months group C- sertraline 50-100 mg/day-for 3 months | Drug | sertraline, psychotherapy |
| placeboplacebo | Drug | placebo, psychotherapy |
| psychotherapypsychotherapy | Other | placebo, psychotherapy, sertraline, psychotherapy |
Primary outcome
depression
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
- Derived from this study: PubMed 22401479Bloch M, Meiboom H, Lorberblatt M, Bluvstein I, Aharonov I, Schreiber S. The effect of sertraline add-on to brief dynamic psychotherapy for the treatment of postpartum depression: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012 Feb;73(2):235-41. doi: 10.4088/JCP.11m07117.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertraline and psychotherapy in people with Postpartum Depression, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 8 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 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
depression (time frame: 12 weeks). 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 NCT01028482, 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 10 May 2011.