Postpartum DepressionNCT02191423
Oxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression
A study testing Oxytocin and Dyadic psychotherapy in people with Postpartum Depression, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Rationale and Hypotheses of the Current Research: the investigators speculate that mothers suffering from PPD exhibit high levels of depression and low levels of OXT, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Oxytocin and Dyadic psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Jun 2016
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of all ages who are 3 to 8 months post-partum.
- Women who have completed a minimum of 12 years of education.
- Women who are willing and able to provide informed consent for their participation and after the study has been explained. Infant participation will be allowed after consent has been obtained from mothers.
- Current DSM-IV-TR diagnosis of PPD disorder as confirmed by SCID (administered as part of the study of protocol number PPD1, proposed to the Helsinki committee on June 2014).
- Symptoms: BDI total score >9, EPDS total score >10
- Treatment with antidepressants will be allowed provided that patients have been on the medication for at least 4 weeks prior to entry into the pre-treatment assessment phase of the study.
Who cannot join
- Unwilling or unable, in the opinion of the investigator, to comply with study instructions.
- Pregnant women.
- Clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).
- Women with significant risk of committing suicide or harming others in the opinion of the psychiatrist.
- Women with a current DSM-IV-TR substance or alcohol abuse. However, patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
- Women who suffers from depression due to physical condition.
- Women who suffers from severe major depression (MADRAS>30)
- Women who suffers from chronic depression (over 6 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oxytocin on Brain Attachment and Empathy Networks, and the Association Between the Brain Response and Treatment Outcome of Brief Dyadic Psychotherapy - in Women Suffering From Postpartum Depression
Rationale and Hypotheses of the Current Research: the investigators speculate that mothers suffering from PPD exhibit high levels of depression and low levels of OXT, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child development. While dyadic psychotherapy has been studied in this context, it is unknown which depressed women will respond to this type of therapy, and whether such a response is mediated by the pro-bonding effect of oxytocin.
The aim of this study is three-fold:
- To study the effect of the administration of a single dose (24IU) of oxytocin on cerebral circuit processing and connectivity of empathy and attachment.
- To examine whether the clinical response of mothers suffering from postpartum depression to short term dyadic psychotherapy (based on improved mother-child interactions) can be predicted by a unique brain response pattern to oxytocin.
- To assess the relationship between levels of oxytocin in mother and baby and the effectiveness of psychological dyadic treatment on mothers suffering from postpartum depression.
- Conditions
- Postpartum Depression
- Being tested
- Oxytocin, placebo, Dyadic psychotherapy
- Keywords
- postpartum Depression, Diadic psychotherapy, Oxytocin, fMRI, attachment, empathy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
administered pre-fMRI assessment
placeboDrug
administered pre-fMRI assessment
Dyadic psychotherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| postpartum depression | Experimental | Women suffering from postpartum depression, assessed by fMRI and then treated by dyadic psychotherapy
1. All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random).
2. All women in this group participate in 8-weeks of dyadic psychotherapy (DP) at the outpatient Psychiatric Department, Tel-Aviv Medical Center.
3. A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS \& STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment. Receives: Drug: Oxytocin; Drug: placebo; Behavioral: Dyadic psychotherapy |
| normal controls | Other | Normal control women not suffering from postpartum depression assessed by fMRI
1. All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random).
2. A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS \& STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment. Receives: Drug: Oxytocin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the administration of oxytocin on cerebral circuit processing
- This paradigm assesses empathic responses to images of individuals experiencing sad, anxious and happy events. Images are preceded by social context (i.e. "this person just won the lottery"). Control condition presents participants with images of people performing everyday actions.
3.we generated 15 short screenplays containing triggers for both types of empathy. Each of the screenplays depicts a situation in which the characters pose a negatively-valenced bodily state (e.g. crying, itching, choking), which we expect to elicit embodied simulation in the viewer.
- This paradigm examines maternal FMRI responses to infant related video vignettes. Stimuli include movies of mothers' own infant vs strange infant during solitary play and mother-infant interaction.
Measured: Two functional brain scans one week after admission to the study (week2)
Interactional measures-CIB
The Coding Interactive Behavior Manual (CIB) (Feldman 1998), a well-validated system for coding dyadic interactions, by individuals blind to the study group that the participant is a member in. The following behaviors will be compute: Parents behavior; Child behavior; Dyadic behavior; Lead-Lag Relationship
Measured: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Interactional measures-Noldus
Micro-analytic coding of synchrony- on a computerized system (Noldus, The Vaggenigen, Netherlands), coded on a computerized system that allows for .01-second exactness. Consistent with previous research on parent-infant synchrony (Feldman and Eidelman, 2004, 2007). Four non-verbal categories of parenting behavior and four non-verbal categories of infant behavior will be coded and each category will include a set of mutually exclusive codes.
Measured: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Secondary outcomes (5)
Maternal depression symptoms measures- BDI
Beck Depression Inventory- BDI (Beck, Ward, Mendelson, Mock, and Erbaugh, 1961) is designed to assess the severity of depression while referring to affective, cognitive, physical and behavioral aspects.
The BDI consists of 21 items, divided in to 3 factors: sadness / negative self perception, psycho-motor deceleration and somatic depression. Every item consists of 4 sentences for self-esteem, in a scale of 0-3, according to the degree of depression. Scores of 9 or above indicate elevated depressive symptoms and a risk for MDD (Kendall, Hollon, Beck, et al 1987). The BDI is a widely used inventory which was found to be well validated and highly coefficient (for a meta analysis see: Beck, Steer, \& Garbin, 1988).
Measured: mothers will complete the BDI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Maternal depression symptoms measures - EPDS
Edinburgh Postnatal Depression Scale- EPDS, (Cox, Holden, Sagovsky, 1987) is designed in order to screen for postnatal depression in the community. The EPDS is a brief (10-item) scale. The questions focus on the psychological rather than the somatic aspects of depression and explore 2 distinct domains of negative affect: depressive symptoms (7 items) and anxiety (3 items) (Kabir, Sheeder and Kelly, 2008). Subjects respond to items on a 4 point Likert scale (of 0-3), resulting in a total score range between 0 and 30. Scores of 10 or above indicate elevated depressive symptoms and a risk for PPD (Cox, Holden, Sagovsky, 1987). The EPDS is a widely used scale which was found to be well validated and highly coefficient (Cox, Holden, Sagovsky, 1987; Kabir, Sheeder and Kelly ,2008; Murray \& Carothers, 1990).
Measured: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Maternal anxiety measures-STAI
State- Trait Anxiety Inventory- STAI (Spielberger, Gorsuch, and Lushene, 1970) assesses levels of situational and trait anxiety. The STAI contains 40 declarations, 20 of which refer to situational anxiety and 20 of which refer to trait anxiety. Subjects will indicate on a scale of 1-4 (1=not it all, 4=to a large extent) to what extent they think the declaration is accurate in their case. Trait anxiety scores of above 43 are considered a risk indicator for anxiety disorders (Spielberger, et al., 1970). The STAI is a widely used inventory which was found to be well validated and highly coefficient (Anastasi, 1988).
Measured: mothers will complete the STAI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Physiological measures-Salivary OXT
Salivary OXT -in order to examine OXT and reactivity curve in PPD women and their infants
Measured: both mothers and infants will give six saliva samples; once a other week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Maternal thought and action measures
Maternal thoughts and actions will be assessed with the Yale Inventory of Parental Thoughts and Actions (YIPTA) - a semi-structured interview which provides a validated measure of parental worries, comprising a range of anxious intrusive thoughts and harm avoidant behaviors (AITHAR; Feldman, Weller, Leckman, Kuint, \& Eidelman, 1999; Leckman et al., 2004; Leckman et al., 1999; Mayes, Swain, Feldman, \& Leckman, 2008). Such thoughts and behaviors include concerns about the baby's physical environment.
Measured: mothers will complete the YIPTA twice; in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191423
- Sponsor's protocol ID
- TASMC-14-MB-161-CTIL
- Status last verified
- Jul 2014
- First submitted
- 9 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxytocin on Brain Attachment and Empathy Networks, and the Association Between the Brain Response and Treatment Outcome of Brief Dyadic Psychotherapy - in Women Suffering From Postpartum Depression
- ClinicalTrials.gov ID
- NCT02191423
- Acronym / sponsor ID
- TASMC-14-MB-161-CTIL
- Conditions
- Postpartum Depression
- Keywords
- postpartum Depression, Diadic psychotherapy, Oxytocin, fMRI, attachment, empathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- First posted
- 16 Jul 2014 (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.
Rationale and Hypotheses of the Current Research: the investigators speculate that mothers suffering from PPD exhibit high levels of depression and low levels of OXT, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child development. While dyadic psychotherapy has been studied in this context, it is unknown which depressed women will respond to this type of therapy, and whether such a response is mediated by the pro-bonding effect of oxytocin.
The aim of this study is three-fold:
- To study the effect of the administration of a single dose (24IU) of oxytocin on cerebral circuit processing and connectivity of empathy and attachment.
- To examine whether the clinical response of mothers suffering from postpartum depression to short term dyadic psychotherapy (based on improved mother-child interactions) can be predicted by a unique brain response pattern to oxytocin.
- To assess the relationship between levels of oxytocin in mother and baby and the effectiveness of psychological dyadic treatment on mothers suffering from postpartum depression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postpartum depression | Experimental | Drug: Oxytocin, Drug: placebo, Behavioral: Dyadic psychotherapyWomen suffering from postpartum depression, assessed by fMRI and then treated by dyadic psychotherapy 1. All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random). 2. All women in this group participate in 8-weeks of dyadic psychotherapy (DP) at the outpatient Psychiatric Department, Tel-Aviv Medical Center. 3. A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS \& STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment. |
| normal controls | Other | Drug: Oxytocin, Drug: placeboNormal control women not suffering from postpartum depression assessed by fMRI 1. All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random). 2. A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS \& STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women of all ages who are 3 to 8 months post-partum.
- Women who have completed a minimum of 12 years of education.
- Women who are willing and able to provide informed consent for their participation and after the study has been explained. Infant participation will be allowed after consent has been obtained from mothers.
- Current DSM-IV-TR diagnosis of PPD disorder as confirmed by SCID (administered as part of the study of protocol number PPD1, proposed to the Helsinki committee on June 2014).
- Symptoms: BDI total score >9, EPDS total score >10
Key exclusion criteria (8 listed)
- Unwilling or unable, in the opinion of the investigator, to comply with study instructions.
- Pregnant women.
- Clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).
- Women with significant risk of committing suicide or harming others in the opinion of the psychiatrist.
- Women with a current DSM-IV-TR substance or alcohol abuse. However, patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
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 |
|---|---|---|
| OxytocinAlso: Syntocinonadministered pre-fMRI assessment | Drug | normal controls, postpartum depression |
| placeboadministered pre-fMRI assessment | Drug | normal controls, postpartum depression |
| Dyadic psychotherapy | Behavioural | postpartum depression |
Primary outcome
Effect of the administration of oxytocin on cerebral circuit processing
Time frame: Two functional brain scans one week after admission to the study (week2)
1. This paradigm assesses empathic responses to images of individuals experiencing sad, anxious and happy events. Images are preceded by social context (i.e. "this person just won the lottery"). Control condition presents participants with images of people performing everyday actions. 3.we generated 15 short screenplays containing triggers for both types of empathy. Each of the screenplays depicts a situation in which the characters pose a negatively-valenced bodily state (e.g. crying, itching, choking), which we expect to elicit embodied simulation in the viewer. 2. This paradigm examines maternal FMRI responses to infant related video vignettes. Stimuli include movies of mothers' own infant vs strange infant during solitary play and mother-infant interaction.
Interactional measures-CIB
Time frame: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
The Coding Interactive Behavior Manual (CIB) (Feldman 1998), a well-validated system for coding dyadic interactions, by individuals blind to the study group that the participant is a member in. The following behaviors will be compute: Parents behavior; Child behavior; Dyadic behavior; Lead-Lag Relationship
Interactional measures-Noldus
Time frame: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Micro-analytic coding of synchrony- on a computerized system (Noldus, The Vaggenigen, Netherlands), coded on a computerized system that allows for .01-second exactness. Consistent with previous research on parent-infant synchrony (Feldman and Eidelman, 2004, 2007). Four non-verbal categories of parenting behavior and four non-verbal categories of infant behavior will be coded and each category will include a set of mutually exclusive codes.
5 secondary outcomes
Maternal depression symptoms measures- BDI
Time frame: mothers will complete the BDI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Maternal depression symptoms measures - EPDS
Time frame: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Maternal anxiety measures-STAI
Time frame: mothers will complete the STAI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Physiological measures-Salivary OXT
Time frame: both mothers and infants will give six saliva samples; once a other week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Maternal thought and action measures
Time frame: mothers will complete the YIPTA twice; in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin and Dyadic 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 6 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: status not confirmed, as of the sponsor's last update on 16 Jul 2014. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miki Bloch, Prof. (972-3-6974707, mikib@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the administration of oxytocin on cerebral circuit processing (time frame: Two functional brain scans one week after admission to the study (week2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2014.