Premenstrual Dysphoric Disorder and Antiepileptic Drugs

NCT00612235 | Completed Results

• 1 other identifier: 2007P000357
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

This study is being done to determine if there are differences in mood during the menstrual cycle among women with epilepsy who take various different antiepileptic drugs and women without epilepsy.

Conditions

Epilepsy

Keywords

epilepsy; lamotrigine; levetiracetam; carbamazepine; phenytoin; lamictal; keppra; tegretol; carbatrol; dilantin

Outcome Measures

Primary Outcomes (2)

• To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies.

  Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria

  Assessment of PMDD Designation after two consecutive menstrual cycles

• Proportion of Women With PMDD in WWE and the Control Group

  Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria.

  Assessment of PMDD Designation after two consecutive menstrual cycles

Study Arms (4)

Lamotrigine Monotherapy

Lamotrigine Monotherapy

Drug: Lamotrigine

Levetiracetam Monotherapy

Levetiracetam Monotherapy

Drug: Levetiracetam

Carbamazepine Monotherapy

Carbamazepine Monotherapy

Drug: Carbamazepine

Normal control (no epilepsy)

Normal control (no epilepsy)

Other: No Intervention

Interventions

Lamotrigine DRUG

Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.

Also known as: Lamictal

Lamotrigine Monotherapy

Levetiracetam DRUG

Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.

Also known as: Keppra

Levetiracetam Monotherapy

Carbamazepine DRUG

Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.

Also known as: Tegretol

Carbamazepine Monotherapy

No Intervention OTHER

No intervention was given

Normal control (no epilepsy)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Three regional epilepsy centers

You may qualify if:

• Women with epilepsy, 18-45 years of age. Women will be on one of 4 established (≥ 3 months) AED monotherapies: LTG, CBZ, PHT or LEV and with documented therapeutic range serum AED level during the year prior to enrollment.
• Normal Control women, 18-45 years of age, in good general health by history

You may not qualify if:

• Concomitant use of prescribed or OTC reproductive hormones
• Concomitant use of antidepressant and anxiolytic medications such as SSRIs, bupropion, tricyclics, benzodiazepines

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Newton-Wellesley Hospital: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Related Publications (1)

• Herzog AG, Smithson SD, Fowler KM, Krishnamurthy KB, Sundstrom D, Kalayjian LA, Heck CN, Oviedo S, Correl-Leyva G, Garcia E, Gleason KA, Dworetzky BA. Premenstrual dysphoric disorder in women with epilepsy: relationships to potential epileptic, antiepileptic drug, and reproductive endocrine factors. Epilepsy Behav. 2011 Aug;21(4):391-6. doi: 10.1016/j.yebeh.2011.05.024. Epub 2011 Jul 2.

  PMID: 21724471 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Epilepsy

Interventions

Lamotrigine; Levetiracetam; Carbamazepine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Andrew G. Herzog M.D., M.Sc.
• Organization: Beth Israel Deaconess Medical Center

aherzog@bidmc.harvard.edu

781-431-0277

Study Officials

• Andrew G Herzog, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 26, 2018
• Results First Posted: October 26, 2018

Record last verified: 2018-01

Locations

US (3)