SAINT in Postpartum Depression (PPD)
ConditionPostpartum Depression (PPD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMagnus Medical
About this trial
This study is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively reduce symptoms of postpartum depression (PPD) compared to a sham treatment.
It will enroll 192 women within 12 months postpartum who are experiencing depression, and will track their progress for up to 12 months. The trial's main goal is to see if SAINT leads to reduction in depression severity in women with postpartum depression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Reproductive Women ages 18-45 at the time of consent.
Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset as assessed through the Quick Structured Clinical Interview for DSM-5.
0-12 months postpartum. Participants must be 0-12 months postpartum at screening and remain within 12 months postpartum at the 5-day post-treatment visit.
If currently taking an antidepressant medication and/or receiving psychotherapy must be on a stable regimen for 30 days at the time of enrollment.
Disqualifiers
Participant has attempted suicide in the last 6 months and/or expressed suicidal ideation with intent as determined by physician assessment at the time of enrollment.
Score of 6 on MADRS item 10 (high rating of suicidal ideation) at screening.
Participant has active psychosis per investigator assessment.
Participant with a primary lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder and/or obsessive-compulsive disorder.
Trial design
Design model
Parallel
Treatments tested in this trial
SAINT Neuromodulation System
DeviceSAINT will be delivered via a MagPro X100 edition (MagVenture, Skovlunde, Denmark) TMS device equipped with a Cool-B65 A/P coil. The stimulation paradigm consists of 10 daily sessions (50 total sessions over 5 days) of SAINT stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be administered at 90% of the participant's resting motor threshold, with depth correction applied to adjust for the measured distance between the scalp and cortical surface. The stimulation target, the L-DLPFC, will be identified and localized by the study investigator using the Localite neuronavigation system.
Sham SAINT Stimulation
DeviceSham stimulation will be delivered using the MagVenture MagPro X100 TMS system with the Cool-B65 A/P coil and targeted to the L-DLPFC. The stimulation paradigm will be identical to the active SAINT stimulation with the exception that active stimulation will not be delivered.
Treatment groups
192 Participants
are divided into 2 treatment groupsGroup A: Active SAINT StimulationActive comparator 1 intervention
Group B: Sham SAINT StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change in depression symptom severity, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment, which will be compared between the acute active SAINT and sham arms.
The change in depression symptom severity will be measured by Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment. Outcomes will be compared between the acute active SAINT and sham arms. Scores range from 0-60 (10 questions, each scored 0-6) with higher scores indicating a worsening of depressive symptoms and lower scores indicating better outcomes.
Time frame
Baseline and 5 days post-acute treatmentOther outcomes
1
The durability of SAINT's effects on symptom severity will be assessed with the Montgomery-Åsberg Depression Rating Scale - Self Report (MADRS-S) using Kaplan-Meier survival curves and Cox proportional hazards models.
Durability of treatment will be assessed from immediately after treatment through six months (180 days) using the Montgomery-Åsberg Depression Rating Scale - Self Report (MADRS-S). The MADRS-S consists of 9 questions, each scored from 0 to 3, with a total score range of 0-27. Higher scores indicate greater depressive symptom severity, while lower scores indicate improvement in symptoms.
Time frame
Baseline, 5 days post acute treatment through 6 months (180 days) post-treatment follow-up (assessed every 14 days).2
Tolerability will be assessed at the 5-day post-acute treatment visit and, if the participant receives open-label SAINT, again at the 5-day post treatment follow-up visit using the Treatment Adherence and Acceptability Scale (TAAS)
Treatment acceptance and adherence will be assessed using the 10-item Treatment Acceptance and Adherence Scale (TAAS). Each item is rated from 1 to 7, for a total score range of 10 to 70. Higher scores indicate greater treatment acceptance and adherence, while lower scores indicate poorer acceptance and adherence.
Time frame
5-day post acute treatment visit and if applicable, 5 days post open-label treatment visit.3
The impact on maternal functioning/bonding will be assessed using the Mother-to-Infant Bonding Scale (MIBS).
An 8-item self-report questionnaire used to assess the early emotional bond between a mother and her infant. Each item is scored 0-3 with a score ranging from 0-24. Higher scores reflect greater bonding difficulties; lower scores reflect more positive bonding.
Time frame
Baseline, 1 month, 3 months, 6 months post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Magnus Medical
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov