Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00302107
Status:
COMPLETED
Last Update Posted:
2014-11-26
First Post:
2006-03-09
Brief Title:
A Placebo-Controlled Study of Mirtazapine for PTSD
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Placebo-Controlled Study of Mirtazapine for PTSD in OIFOEF Veterans
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective To study the efficacy and tolerability of mirtazapine Remeron in the treatment of PTSD
Research Design This is an 8-week randomized double-blind placebo-controlled treatment trial of mirtazapine for the treatment of PTSD as defined on the Clinical Assessment of PTSD Scale CAPS
Methodology After signing an informed consent and meeting all inclusionexclusion criteria the patient is randomized to either mirtazapine versus placebo for 8-week duration During the study a pharmacist maintains the randomization log and verifies the order for the placebo or mirtazapine in look-a-like tablets Patients symptoms side effects and compliance are assessed bi-weekly Based on symptomology and occurrence of side effects the investigator increases the medication in 15 mg increments as tolerated until a maximum therapeutic benefit is achieved not to exceed 45 mgday The dosing is at bedtime Compliance is assessed by bi-weekly pill count at week 4 and week 8 Patients are given supportive clinical management during the clinic visits An investigator is available by telephone 24 hrs a day in case of emergency Patients may be seen more often if needed Efficacy will be measured by the following assessment scales Montgomery-Asberg Depression Rating Scale MADRS Hamilton Anxiety Scale Ham-A Clinical Global Impression Severity of Illness CGI-s Clinical Global Impression of Improvement CGI-I Global Assessment of Functioning GAF CAPS Treatment Outcome PTSD rating scale TOP-8 and Davidson Trauma Scale DTS
Clinical Significance Mirtazapine has shown promise in treating PTSD in an open label trial This study is the next step in proving mirtazapines efficacy in treatment of PTSD
Research Design This is an 8-week randomized double-blind placebo-controlled treatment trial of mirtazapine for the treatment of PTSD as defined on the Clinical Assessment of PTSD Scale CAPS
Methodology After signing an informed consent and meeting all inclusionexclusion criteria the patient is randomized to either mirtazapine versus placebo for 8-week duration During the study a pharmacist maintains the randomization log and verifies the order for the placebo or mirtazapine in look-a-like tablets Patients symptoms side effects and compliance are assessed bi-weekly Based on symptomology and occurrence of side effects the investigator increases the medication in 15 mg increments as tolerated until a maximum therapeutic benefit is achieved not to exceed 45 mgday The dosing is at bedtime Compliance is assessed by bi-weekly pill count at week 4 and week 8 Patients are given supportive clinical management during the clinic visits An investigator is available by telephone 24 hrs a day in case of emergency Patients may be seen more often if needed Efficacy will be measured by the following assessment scales Montgomery-Asberg Depression Rating Scale MADRS Hamilton Anxiety Scale Ham-A Clinical Global Impression Severity of Illness CGI-s Clinical Global Impression of Improvement CGI-I Global Assessment of Functioning GAF CAPS Treatment Outcome PTSD rating scale TOP-8 and Davidson Trauma Scale DTS
Clinical Significance Mirtazapine has shown promise in treating PTSD in an open label trial This study is the next step in proving mirtazapines efficacy in treatment of PTSD
Detailed Description:
Title A Placebo-Controlled Study of Mirtazapine for PTSD in OIFOEF Veterans and Veterans from all other Southwest Asia Conditions
Sponsor of the study VA Merit grant
Research Setting Subjects will be recruited from the mental health and primary care outpatient clinics and inpatient units The informed consent process will be conducted in a private setting Rating scales and laboratory procedures will also be performed in a private setting
Purpose of the study including hypothesis to be tested The primary objective is to evaluate the efficacy and tolerability of mirtazapine Remeron in the treatment of PTSD Primary Hypothesis to be tested Veterans with PTSD will have improvement in their symptomatology after 8 weeks of treatment with mirtazapine compared to those treated with placebo
Background including results of relevant research gaps in the current knowledge PTSD is a common mental illness afflicting about 3 percent of persons or 12 million North Americans PTSD is a common consequence of disasters rape auto accidents and violent crime with about half of trauma victims suffering acute symptoms One fourth of victims of acute PTSD progress to develop chronic PTSD Presently there are only two medications indicated for PTSD sertraline and paroxetine Long-term effects of untreated PTSD are serious including depression alcohol and drug abuse violence and suicide The VA Healthcare System is a natural clinical laboratory for study of PTSD since 14 - 30 of Vietnam Combat Veterans continue to suffer consequences of this disorder Preliminary clinical data from an open studies and one small placebo-controlled study of mirtazapine in the treatment of PTSD suggests that mirtazapine is effective and may have a unique pharmacological profile in treating PTSD
Potential Benefits to the research subject and knowledge to be gained The actual patient participant may benefit from further reduction in underlying psychiatric symptoms There is substantial potential for knowledge about PTSD treatment to be gained by the cumulative data gathered in this study that may improve the health care of veterans and nonveterans in the future
Definition of the population to be studied and justification The population to be studied is outpatient veterans with current PTSD diagnosed by the use of the MINI Patients may be recruited from mental health inpatient units or Primary Care Outpatient Clinics however the majority of the study is intended to be outpatient The justification for use of a PTSD population is that new treatments for PTSD are needed particularly with combination of medications since monotherapy rarely is fully effective
Number of subjects 100 subjects enrolled Subjects must meet each of the following inclusion and exclusion criteria in order to be randomized
Subject inclusion criteria
Diagnosis of PTSD confirmed by MINI and CAPS
Age 19 or older
No substance abusedependence for the previous 4 weeks except for nicotine and caffeine
Free of psychotropic medication for 2 weeks except 4 weeks for fluoxetine
Clinically normal physical and laboratory examination lab profile listed below Liver function tests LFTs up to 25 times the normal limit will be allowed
Women of childbearing potential must be using medically approved methods of birth control such as a condom birth control pill Depo-Provera or diaphragm with spermicides
Signed informed consent
Male or female any race or ethnic origin
Exclusion criteria
Lifetime history of bipolar I psychotic or cognitive disorders
Actively suicidal homicidal or psychotic
History of sensitivity to mirtazapine
Unstable general medical conditions
Score 6 on Question 10 of MADRS regarding suicidal ideation
Women who are pregnant planning to become pregnant or breastfeed during the study
Exit Criteria One needed to exit
Completion of the study
Severe and intolerable side effects to mirtazapineplacebo treatment
Acute development of suicidal ideation homicidal ideation or psychotic symptoms
Symptoms worsen Score of 7 very much worse on CGI-I
Participants explicit request to exit the study
The need for additional psychotropic drugs other than the study drug or adjunctive medication as specified in the protocol for the control of the subjects psychiatric symptoms
The subject becomes pregnant during the course of the study
Investigators judgment that it is no longer in the best interest of the patient to continue in the study
Sponsor of the study VA Merit grant
Research Setting Subjects will be recruited from the mental health and primary care outpatient clinics and inpatient units The informed consent process will be conducted in a private setting Rating scales and laboratory procedures will also be performed in a private setting
Purpose of the study including hypothesis to be tested The primary objective is to evaluate the efficacy and tolerability of mirtazapine Remeron in the treatment of PTSD Primary Hypothesis to be tested Veterans with PTSD will have improvement in their symptomatology after 8 weeks of treatment with mirtazapine compared to those treated with placebo
Background including results of relevant research gaps in the current knowledge PTSD is a common mental illness afflicting about 3 percent of persons or 12 million North Americans PTSD is a common consequence of disasters rape auto accidents and violent crime with about half of trauma victims suffering acute symptoms One fourth of victims of acute PTSD progress to develop chronic PTSD Presently there are only two medications indicated for PTSD sertraline and paroxetine Long-term effects of untreated PTSD are serious including depression alcohol and drug abuse violence and suicide The VA Healthcare System is a natural clinical laboratory for study of PTSD since 14 - 30 of Vietnam Combat Veterans continue to suffer consequences of this disorder Preliminary clinical data from an open studies and one small placebo-controlled study of mirtazapine in the treatment of PTSD suggests that mirtazapine is effective and may have a unique pharmacological profile in treating PTSD
Potential Benefits to the research subject and knowledge to be gained The actual patient participant may benefit from further reduction in underlying psychiatric symptoms There is substantial potential for knowledge about PTSD treatment to be gained by the cumulative data gathered in this study that may improve the health care of veterans and nonveterans in the future
Definition of the population to be studied and justification The population to be studied is outpatient veterans with current PTSD diagnosed by the use of the MINI Patients may be recruited from mental health inpatient units or Primary Care Outpatient Clinics however the majority of the study is intended to be outpatient The justification for use of a PTSD population is that new treatments for PTSD are needed particularly with combination of medications since monotherapy rarely is fully effective
Number of subjects 100 subjects enrolled Subjects must meet each of the following inclusion and exclusion criteria in order to be randomized
Subject inclusion criteria
Diagnosis of PTSD confirmed by MINI and CAPS
Age 19 or older
No substance abusedependence for the previous 4 weeks except for nicotine and caffeine
Free of psychotropic medication for 2 weeks except 4 weeks for fluoxetine
Clinically normal physical and laboratory examination lab profile listed below Liver function tests LFTs up to 25 times the normal limit will be allowed
Women of childbearing potential must be using medically approved methods of birth control such as a condom birth control pill Depo-Provera or diaphragm with spermicides
Signed informed consent
Male or female any race or ethnic origin
Exclusion criteria
Lifetime history of bipolar I psychotic or cognitive disorders
Actively suicidal homicidal or psychotic
History of sensitivity to mirtazapine
Unstable general medical conditions
Score 6 on Question 10 of MADRS regarding suicidal ideation
Women who are pregnant planning to become pregnant or breastfeed during the study
Exit Criteria One needed to exit
Completion of the study
Severe and intolerable side effects to mirtazapineplacebo treatment
Acute development of suicidal ideation homicidal ideation or psychotic symptoms
Symptoms worsen Score of 7 very much worse on CGI-I
Participants explicit request to exit the study
The need for additional psychotropic drugs other than the study drug or adjunctive medication as specified in the protocol for the control of the subjects psychiatric symptoms
The subject becomes pregnant during the course of the study
Investigators judgment that it is no longer in the best interest of the patient to continue in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None