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Trial record 99 of 107 for:    PHENYTOIN

Premenstrual Dysphoric Disorder and Antiepileptic Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00612235
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborators:
Newton-Wellesley Hospital
Brigham and Women's Hospital
Information provided by (Responsible Party):
Andrew Herzog, Beth Israel Deaconess Medical Center

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Epilepsy
Interventions Drug: Lamotrigine
Drug: Levetiracetam
Drug: Carbamazepine
Other: No Intervention
Enrollment 80
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title 1 Lamotrigine Monotherapy 2 Levetiracetam Monotherapy 3 Carbamazepine Monotherapy 5 Normal Control
Hide Arm/Group Description Women with Epilepsy on Lamotrigine Monotherapy Women with Epilepsy on Levetiracetam Monotherapy Women with Epilepsy on Carbamazepine Monotherapy Normal Control Women(no epilepsy)
Period Title: Overall Study
Started 20 20 20 20
Completed 20 20 20 20
Not Completed 0 0 0 0
Arm/Group Title 1 Lamotrigine Monotherapy 2 Levetiracetam Monotherapy 3 Carbamazepine Monotherapy 5 Normal Control Total
Hide Arm/Group Description Women with Epilepsy on Lamotrigine Monotherapy Women with Epilepsy on Levetiracetam Monotherapy Women with Epilepsy on Carbamazepine Monotherapy Normal Control Women(no epilepsy) Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 20 80
Hide Baseline Analysis Population Description
Women with epilepsy on antiepileptic drug monotherapies and normal controls. There was no difference in the number who started and completed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
80
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
32.44  (8.06) 33.08  (7.57) 29.93  (8.74) 31.79  (8.21) 31.75  (8.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
Female
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
80
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
20 20 20 20 80
1.Primary Outcome
Title To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies.
Hide Description 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
Time Frame Assessment of PMDD Designation after two consecutive menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 Carbamazepine Monotherapy 2 Levetiracetam Monotherapy 1 Lamotrigine Monotherapy
Hide Arm/Group Description:
Women with Epilepsy on Carbamazepine Monotherapy
Women with Epilepsy on Levetiracetam Monotherapy
Women with Epilepsy on Lamotrigine Monotherapy
Overall Number of Participants Analyzed 20 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
Endicott PMDD Designation
0
   0.0%
0
   0.0%
0
   0.0%
Less Stringent Threshold for PMDD Designation
2
  10.0%
2
  10.0%
2
  10.0%
No PMDD Designation
18
  90.0%
18
  90.0%
18
  90.0%
2.Primary Outcome
Title Proportion of Women With PMDD in WWE and the Control Group
Hide Description 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.
Time Frame Assessment of PMDD Designation after two consecutive menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women With Epilepsy Control Group
Hide Arm/Group Description:
Women with Epilepsy
Women without Epilepsy
Overall Number of Participants Analyzed 60 20
Measure Type: Count of Participants
Unit of Measure: Participants
Endicott PMDD Designation
0
   0.0%
0
   0.0%
Less Stringent Threshold for PMDD Designation
6
  10.0%
2
  10.0%
No PMDD Designation
54
  90.0%
18
  90.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lamotrigine Levetiracetam Carbamazepine Control
Hide Arm/Group Description Women with Epilepsy on Lamotrigine Monotherapy Women with Epilepsy on Levetiracetam Monotherapy Women with Epilepsy on Carbamazepine Monotherapy Normal control (no epilepsy)
All-Cause Mortality
Lamotrigine Levetiracetam Carbamazepine Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine Levetiracetam Carbamazepine Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lamotrigine Levetiracetam Carbamazepine Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Andrew G. Herzog M.D., M.Sc.
Organization: Beth Israel Deaconess Medical Center
Phone: 781-431-0277
Responsible Party: Andrew Herzog, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00612235     History of Changes
Other Study ID Numbers: 2007P000357
First Submitted: January 29, 2008
First Posted: February 11, 2008
Results First Submitted: March 16, 2017
Results First Posted: October 26, 2018
Last Update Posted: October 26, 2018