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| ID | Type | Description | Link |
|---|---|---|---|
| 01641 | Other Identifier | VA IRB |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization will be done using 3:1 ratio and will be performed by our research pharmacy using a random assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo. Medication will be titrated over a 6 week titration phase followed by a 6 week treatment phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will be provided by trained and qualified clinicians with extensive experience providing E-CPT-C. Veterans will be recruited primarily through advertisement, but also through the clinical facilities at the VA and from other collaborators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zonisamide | Experimental | Participants in this arm will receive zonisamide for 12 weeks. |
|
| Placebo | Placebo Comparator | Participants in this arm will receive placebo medication for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced-Cognitive Processing Therapy-C (E-CPT-C) | Behavioral |
| ||
| Zonisamide |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinking Days | Using a 90 day Timeline Follow Back (TLFB), the total number of drinking days at baseline and at 12 weeks of treatment were used. | 12 weeks |
| Number of Heavy Drinking Days | Timeline Follow Back (TLFB) will be used to document the number of "heavy" drinking days during 12 weeks of treatment. Heavy drinking is defined as greater than or equal to 5 drinks for men and greater than or equal to 4 drinks for women. | 12 weeks |
| Clinician-Administered PTSD Scale (CAPS) Total Score | The Clinician-Administered PTSD Scale (CAPS) Total Score will be used to measure PTSD symptoms at the end of the 12 week intervention. The CAPS Total Score is a summing of the 17 items that are each scored 0-4- where 0 indicates "none". The range of Total Scores can be 0 to 136, where 136 would be the highest amount of scored PTSD symptoms. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ismene Petrakis, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System | West Haven | Connecticut | 06516 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zonisamide | Participants in this arm will receive zonisamide for 12 weeks. Enhanced-Cognitive Processing Therapy-C (E-CPT-C) Zonisamide |
| FG001 | Placebo | Participants in this arm will receive placebo medication for 12 weeks. Enhanced-Cognitive Processing Therapy-C (E-CPT-C) Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zonisamide | Participants in this arm will receive zonisamide for 12 weeks. Enhanced-Cognitive Processing Therapy-C (E-CPT-C) Zonisamide |
| BG001 | Placebo | Participants in this arm will receive placebo medication for 12 weeks. Enhanced-Cognitive Processing Therapy-C (E-CPT-C) Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Drinking Days | Using a 90 day Timeline Follow Back (TLFB), the total number of drinking days at baseline and at 12 weeks of treatment were used. | The intention to treat population was used in the analysis. | Posted | Mean | Standard Error | days | 12 weeks |
|
12 weeks
Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zonisamide | Participants in this arm will receive zonisamide for 12 weeks. Enhanced-Cognitive Processing Therapy-C (E-CPT-C) Zonisamide |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment | Patient hospitalized due to intoxication and suicidal ideation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Difficulty Sleeping | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ismene Petrakis | Yale University School of Medicine, VA Connecticut Healthcare System | (203) 932-5711 | ismene.petrakis@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2015 | Dec 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000078305 | Zonisamide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Drug |
|
|
| Placebo | Drug |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Heavy Drinking Days | Timeline Follow Back (TLFB) will be used to document the number of "heavy" drinking days during 12 weeks of treatment. Heavy drinking is defined as greater than or equal to 5 drinks for men and greater than or equal to 4 drinks for women. | The intention to treat population was used in the analysis. | Posted | Mean | Standard Error | days | 12 weeks |
|
|
|
| Primary | Clinician-Administered PTSD Scale (CAPS) Total Score | The Clinician-Administered PTSD Scale (CAPS) Total Score will be used to measure PTSD symptoms at the end of the 12 week intervention. The CAPS Total Score is a summing of the 17 items that are each scored 0-4- where 0 indicates "none". The range of Total Scores can be 0 to 136, where 136 would be the highest amount of scored PTSD symptoms. | The intention to treat population was used in the analysis. | Posted | Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
| 0 |
| 18 |
| 1 |
| 18 |
| 6 |
| 18 |
| EG001 | Placebo | Participants in this arm will receive placebo medication for 12 weeks. Enhanced-Cognitive Processing Therapy-C (E-CPT-C) Placebo | 0 | 6 | 2 | 6 | 2 | 6 |
|
| Fall | General disorders | Non-systematic Assessment | Patient taken to emergency care following a fall. |
|
| Breast Swelling | Infections and infestations | Non-systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Decreased Libido | Psychiatric disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Memory Impairment | Nervous system disorders | Systematic Assessment |
|
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| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| Sulfur Compounds |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |