Trial Outcomes & Findings for Premenstrual Dysphoric Disorder and Antiepileptic Drugs (NCT NCT00612235)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

80 participants

Primary outcome timeframe

Assessment of PMDD Designation after two consecutive menstrual cycles

Results posted on

2018-10-26

Participant Flow

The 3 participating sites enrolled 60 women with epilepsy, 20 in each of the 3 antiepileptic drug groups, and 20 normal controls between 4/1/2008 and 3/31/2010. All of the women met inclusion and exclusion criteria. No enrolled subject was excluded after enrollment.

Since the original conceptualization of the study, phenytoin use declined among women with epilepsy in the general population to the point that we did not identify a sufficient base population in our initial screen to proceed with enrollment of this group and the decision was made at the start of the study to exclude this drug group.

Participant milestones

Participant milestones
Measure	1 Lamotrigine Monotherapy Women with Epilepsy on Lamotrigine Monotherapy	2 Levetiracetam Monotherapy Women with Epilepsy on Levetiracetam Monotherapy	3 Carbamazepine Monotherapy Women with Epilepsy on Carbamazepine Monotherapy	5 Normal Control Normal Control Women(no epilepsy)
Overall Study STARTED	20	20	20	20
Overall Study COMPLETED	20	20	20	20
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 Lamotrigine Monotherapy n=20 Participants Women with Epilepsy on Lamotrigine Monotherapy	2 Levetiracetam Monotherapy n=20 Participants Women with Epilepsy on Levetiracetam Monotherapy	3 Carbamazepine Monotherapy n=20 Participants Women with Epilepsy on Carbamazepine Monotherapy	5 Normal Control n=20 Participants Normal Control Women(no epilepsy)	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	20 Participants n=4 Participants	80 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	32.44 years STANDARD_DEVIATION 8.06 • n=5 Participants	33.08 years STANDARD_DEVIATION 7.57 • n=7 Participants	29.93 years STANDARD_DEVIATION 8.74 • n=5 Participants	31.79 years STANDARD_DEVIATION 8.21 • n=4 Participants	31.75 years STANDARD_DEVIATION 8.22 • n=21 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	20 Participants n=4 Participants	80 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	20 participants n=4 Participants	80 participants n=21 Participants

PRIMARY outcome

Timeframe: Assessment of PMDD Designation after two consecutive menstrual cycles

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

Outcome measures

Outcome measures
Measure	3 Carbamazepine Monotherapy n=20 Participants Women with Epilepsy on Carbamazepine Monotherapy	2 Levetiracetam Monotherapy n=20 Participants Women with Epilepsy on Levetiracetam Monotherapy	1 Lamotrigine Monotherapy n=20 Participants Women with Epilepsy on Lamotrigine Monotherapy
To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. Endicott PMDD Designation	0 Participants	0 Participants	0 Participants
To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. Less Stringent Threshold for PMDD Designation	2 Participants	2 Participants	2 Participants
To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. No PMDD Designation	18 Participants	18 Participants	18 Participants

PRIMARY outcome

Timeframe: Assessment of PMDD Designation after two consecutive menstrual cycles

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.

Outcome measures

Outcome measures
Measure	3 Carbamazepine Monotherapy n=60 Participants Women with Epilepsy on Carbamazepine Monotherapy	2 Levetiracetam Monotherapy n=20 Participants Women with Epilepsy on Levetiracetam Monotherapy	1 Lamotrigine Monotherapy Women with Epilepsy on Lamotrigine Monotherapy
Proportion of Women With PMDD in WWE and the Control Group Endicott PMDD Designation	0 Participants	0 Participants	—
Proportion of Women With PMDD in WWE and the Control Group Less Stringent Threshold for PMDD Designation	6 Participants	2 Participants	—
Proportion of Women With PMDD in WWE and the Control Group No PMDD Designation	54 Participants	18 Participants	—

Adverse Events

Lamotrigine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Levetiracetam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carbamazepine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew G. Herzog M.D., M.Sc.

Beth Israel Deaconess Medical Center

Phone: 781-431-0277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place