Neurofeedback Treatment of Affective Instability in Premenstrual Dysphoric Disorder(PMDD)

NCT01945372 | Unknown DMC

• 1 other identifier: TASMC-13-TH-0295-13-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Premenstrual Dysphoric Disorder (PMDD) is characterized by affective instability and irritability, diagnosed in 5% of reproductive-age women. Although causing severe insult to patients' functioning and quality of life, \~40% do not respond to conventional treatment options. In this study, the investigators aim to examine a novel therapeutic approach for the treatment of affective instability in PMDD: brain-guided training (i.e.NeuroFeedBack, NF) probed by prefrontal EEG alpha asymmetry. PMDD patients will be randomly assigned to either a real or sham EEG-NF protocol, and undergo simultaneous fMRI-EEG scans before and after training period. Comprehensive psychological assessment will be performed for outcome measure. The investigators hypothesize that EEG-NF treatment will enhance affective stability, thus improving patients' daily lives.

Conditions

Depression; Premenstrual Dysphoric Disorder (PMDD)

Outcome Measures

Primary Outcomes (1)

• PMDD symptoms

  Will be assessed by the score on the PMTS questionnaire before, during and after the intervention.

  Up to 24 months

Study Arms (2)

EEG NeuroFeedback - real feedback

EXPERIMENTAL

Thw women in the experimental group will receive accurate realtime feedback corresponding to their performance on the task.

Other: EEG NeuroFeedback

EEG NeuroFeedback - sham feedback

SHAM COMPARATOR

The women in the sham group will receive neural feedback from another person in the study, thus unrelated to their mental practice

Other: EEG NeuroFeedback

Interventions

EEG NeuroFeedback OTHER

EEG NeuroFeedback - real feedback; EEG NeuroFeedback - sham feedback

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Reported at least a 1-year history of regularly experiencing PMDD.
• Will fulfill screening criteria of the Premenstrual Screening Tool (PSST) for PMDD (a. at least 1 of 4 "core PMS" symptoms rated severe, b. at least 4 additional premenstrual symptoms rated either moderate or severe, and c. at least 1of 5 "functional" items rated severe) (Steiner, Macdougall et al. 2003) 3. Are diagnosed prospectively (using the Daily Record of Severity of Problems - DRSP criteria) by two full monthly cycles of daily symptom charting. A cycle will be considered symptomatic if the luteal phase mean score will be 30% greater than the mean follicular phase score (Endicott et al.2006)
• \. Upon admission to the study, meet diagnostic criteria for PMDD on the basis of a structured interview for making psychiatric diagnoses according to the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition)(DSM-IV).

You may not qualify if:

• Current pregnancy or breastfeeding
• Women using an oral contraceptive or a hormonal IUD.
• Current anti-depressant pharmacological treatment.
• Meet at admission axis I DSM IV diagnosis. for a current major depressive episode or a psychotic disorder.
• Substance dependence or abuse other than nicotine in the 30 days prior to screening.
• Patients with an acute or chronic condition that might be harmed by the proposed treatment according to the judgment of the clinical Investigator.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Depression; Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2013
• First Posted: September 18, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 16, 2018

Record last verified: 2013-09

Locations

IL (1)