Sertraline for Premenstrual Dysphoric Disorder

(BLOOM Trial)

Recruiting at 1 trial location

Overseen By Victoria Paone, B.S.

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Must not be taking: Psychiatric meds, MAOIs, pimozide, disulfiram

Disqualifiers: Substance use, Psychotic disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 2-3 months

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how a low-dose antidepressant, sertraline, affects women with premenstrual dysphoric disorder (PMDD), a severe form of PMS. Researchers will compare the blood levels of certain hormones and brain chemicals in women with and without PMDD at different times in the menstrual cycle. Participants with PMDD will receive either sertraline or a placebo to assess its impact on their symptoms. Women who experience severe mood swings and discomfort before their periods may be well-suited for this trial. As a Phase 4 trial, this research focuses on how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

Yes, you will need to stop taking psychiatric medications, steroid hormones, hormonal contraceptives, and certain other medications like methylene blue, linezolid, MAOIs, pimozide, and disulfiram at least 2 months before joining the trial.

What is the safety track record for sertraline?

Research has shown that sertraline is generally well-tolerated for treating premenstrual dysphoric disorder (PMDD). People taking sertraline, either regularly or occasionally, often report feeling better compared to those taking a placebo, a pill with no active medicine. This indicates that sertraline is effective and manageable for most individuals.

Additionally, the FDA has approved sertraline specifically for PMDD, confirming that it has been thoroughly studied and found safe for many people.

In summary, for those considering joining a trial, existing evidence suggests that sertraline is generally safe and well-tolerated for managing PMDD. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike many standard treatments for premenstrual dysphoric disorder (PMDD), which often involve long-term daily medication, sertraline offers a unique approach by being taken only during the luteal phase of the menstrual cycle. This targeted administration could potentially reduce side effects and improve adherence, as patients don't need to take the medication every day of the month. Researchers are also excited because sertraline, a selective serotonin reuptake inhibitor (SSRI), is well-known for its effectiveness in mood regulation, which is a key component in managing PMDD symptoms. This approach could offer faster relief during the most symptomatic time, aligning treatment with the specific timing of PMDD symptoms.

What evidence suggests that sertraline might be an effective treatment for PMDD?

Research has shown that sertraline can help treat premenstrual dysphoric disorder (PMDD). In this trial, participants in the "PMDD with sertraline" arm will take sertraline during the second half of the menstrual cycle, a method shown to improve mood and physical symptoms. Women taking sertraline experienced much less severe PMDD symptoms than those taking a placebo. This effect may occur because sertraline increases serotonin levels, helping control mood swings and other emotional symptoms. Overall, evidence supports sertraline as an effective treatment for PMDD. ^{2 5 6 7 8}

Who Is on the Research Team?

Liisa Hantsoo, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for English-speaking women aged 18-50 with regular menstrual cycles who have Premenstrual Dysphoric Disorder (PMDD). Participants must be able to give written consent. It's not specified who can't join, but typically those with health conditions affecting the study may be excluded.

Inclusion Criteria

I am fluent in English.

My menstrual cycles are regular, lasting 24-35 days.

I can sign and understand the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants track mood, answer surveys, and complete blood draws across two menstrual cycles. In the second cycle, PMDD participants take sertraline or placebo from ovulation until menses onset.

2-3 months

8 visits (in-person) for PMDD groups, 4 visits (in-person) for control group

Follow-up

Participants are monitored for changes in neuroactive steroid levels and GABAAR subunit expression after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sertraline

Trial Overview The trial is testing whether sertraline, an SSRI medication commonly used for depression and PMDD, affects certain brain chemicals during the luteal phase of the menstrual cycle compared to a placebo. The focus is on how this treatment impacts GABA receptors and related neurosteroids in PMDD patients.

How Is the Trial Designed?

Group I: PMDD with sertraline Active Control 1 Intervention

Participants delegated to the "PMDD with sertraline" arm will be individuals with severe premenstrual symptoms in the luteal phase of the menstrual cycle. Participants will be asked to track mood across two menstrual cycles, answer self-report surveys, and complete eight blood draws (four in each menstrual cycle). In the second cycle, participants in this arm will take a daily pill of 50 mg of sertraline from ovulation until menses onset (end of menstrual cycle 2).

Group II: Control Active Control 1 Intervention

Participants delegated to the "control" arm will be individuals without premenstrual symptoms in the luteal phase of the menstrual cycle. Participants will be asked to track mood across the menstrual cycle, answer self-report surveys, and complete four blood draws.

Group III: PMDD with placebo Placebo Group 1 Intervention

Participants delegated to the "PMDD with placebo" arm will be individuals with severe premenstrual symptoms in the luteal phase of the menstrual cycle. Participants will be asked to track mood across two menstrual cycles, answer self-report surveys, and complete eight blood draws (four in each menstrual cycle). In the second cycle, participants in this arm will take a daily placebo pill from ovulation until menses onset (end of menstrual cycle 2).

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Sertraline is a well-tolerated selective serotonin reuptake inhibitor that effectively treats various depressive and anxiety disorders, showing efficacy even in patients with psychiatric and medical comorbidities.

It is effective for both short-term and long-term management of conditions like major depressive disorder, social anxiety disorder, PTSD, panic disorder, generalized anxiety disorder, and OCD, with a low risk of fatal toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based review of the clinical use of sertraline in mood and anxiety disorders. Sheehan, DV., Kamijima, K.[2022]

In a study involving 1251 patients, sertraline was found to have a similar safety profile to other SSRIs, with common side effects like nausea, headache, and diarrhea reported by both groups.

Despite the similarities, sertraline users reported a higher incidence of diarrhea compared to users of other SSRIs, and the study identified over 100 different unlabelled adverse events, indicating the need for ongoing monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in users of sertraline: results from an observational study in psychiatric practice in The Netherlands. Meijer, WE., Heerdink, ER., van Eijk, JT., et al.[2022]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2436278

Symptom-Onset Dosing of Sertraline for the Treatment ... This study compares the effectiveness of sertraline vs placebo in a sample of women with premenstrual dysphoric disorder.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9501889/

Treatment of Premenstrual Dysphoric Disorder With ... This study is the first to demonstrate a significant response to a serotonin selective reuptake inhibitor used only during the luteal phase.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00536198

Evaluating the Effectiveness of Sertraline in Treating ... Study Overview. This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder. ...

4. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.161.2.343

Continuous or Intermittent Dosing With Sertraline for ... RESULTS: Both sertraline groups improved significantly more than the placebo group as assessed by total premenstrual Daily Symptom Rating Form scores for 3 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S108707922500022X

The impact of pharmacotherapy for premenstrual dysphoric ... Likely mediated through their stimulatory effects on serotonin, TCAs may help alleviate premenstrual irritability and related symptoms. Supporting their ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC353031/

Premenstrual Dysphoric Disorder: Recognition and Treatment Sertraline is very well tolerated using both dosing strategies. ... Finally, it should be noted that an analysis of symptoms in the first 3 days after stopping ...

7. aafp.org aafp.org/pubs/afp/issues/2002/1001/p1239.html?printable=afp

Diagnosis and Treatment of Premenstrual Dysphoric ... It should also be noted that fluoxetine and sertraline are the only two SSRIs with FDA approval for use in the treatment of PMDD. Alprazolam, a ...

8. womensmentalhealth.org womensmentalhealth.org/posts/does-symptom-onset-dosing-of-an-ssri-work-for-pmdd/

For PMDD, Does Symptom-Onset Dosing of an SSRI Work? In this study, women receiving sertraline experienced a greater reduction in the “interference” or overall impact of PMDD symptoms than those ...