Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182078
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2005-09-14
Brief Title:
A Study of Sertraline to Prevent PTSD
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Study of Sertraline to Prevent PTSD
Status:
COMPLETED
Status Verified Date:
2014-07
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:
The broad long-term objectives of this proposal are to prevent the emergence of posttraumatic stress and depressive symptoms in children admitted for an acute burn reconstructive surgery or non-burn injury This study is investigating the early use of a medication in the prevention of posttraumatic stress disorder and depression Specific Aims 1 and 2 To assess the efficacy of sertraline to prevent the development of Aim 1posttraumatic stress disorder and Aim 2depression in children aged 6-20 after burn or non-burn injury or after reconstructive surgery Hypotheses 1 and 2 Administration of sertraline after an acute burn or non-burn injury or after reconstructive surgery will lead to greater reduction in post-traumatic and depressive symptoms over 12 and 24 weeks compared with placebo
This study is completing the evaluation of 90 children and adolescents aged 6-20 years It is comparing 60 subjects receiving sertraline with 30 placebo control subjects matched for age severity of injury and type of hospitalization acute vs reconstructive Children and families are evaluated for the presence of acute stress symptoms Children are reassessed in a double-blind placebo-controlled design with evaluations at Baseline Week 2 Week 4 Week 8 Week 12 and Week 24 In addition there is weekly monitoring for the first 14 weeks of the study and again at 18 weeks the midpoint of the study At each reassessment information is collected on the childs compliance with the study medication the parents assessment of the childs functioning and the childs self-report of posttraumatic and depressive symptomatology The main outcome variable used in this study is the childs posttraumatic symptoms
This study is completing the evaluation of 90 children and adolescents aged 6-20 years It is comparing 60 subjects receiving sertraline with 30 placebo control subjects matched for age severity of injury and type of hospitalization acute vs reconstructive Children and families are evaluated for the presence of acute stress symptoms Children are reassessed in a double-blind placebo-controlled design with evaluations at Baseline Week 2 Week 4 Week 8 Week 12 and Week 24 In addition there is weekly monitoring for the first 14 weeks of the study and again at 18 weeks the midpoint of the study At each reassessment information is collected on the childs compliance with the study medication the parents assessment of the childs functioning and the childs self-report of posttraumatic and depressive symptomatology The main outcome variable used in this study is the childs posttraumatic symptoms
Detailed Description:
RESEARCH DESIGN AND METHODS
1 SPECIFIC AIM 1 To assess the efficacy of sertraline in preventing posttraumatic stress disorder in children aged 6-20 after a burn injury or reconstructive surgery following a burn injury
2 SPECIFIC AIM 2 To assess the efficacy of sertraline in preventing co-morbid depression in children aged 6-20 after a burn injury or reconstructive surgery following a burn injury
BACKGROUND AND SIGNIFICANCE Prevention of posttraumatic stress symptoms is a priority in psychiatric practice today This is the first controlled study of any medication to prevent posttraumatic stress disorder PTSD in children and adolescents The purpose of the study is to use sertraline to prevent PTSD and co-morbid depression from developing in 6-20 year old children hospitalized with a burn injury or reconstructive surgery following a burn injury If this intervention is successful it will help to prevent psychiatric and developmental disorders in injured children as well as those who undergo reconstructive procedures While we have found no studies that have investigated the efficacy of sertraline in treating PTSD in children and adolescents research indicates that sertraline is effective in treating other anxiety disorders and depression in children and adolescents Research also indicates that sertraline is effective in treating PTSD in adults
RECRUITMENT PROCEDURES Families of children aged 6-20 admitted with an acute burn or for reconstructive surgery are contacted by study staff within 3 days of admission or when medically stable and asked to participate in the study In addition 6-17 year old patients admitted for an injury are asked to participate
CONSENT PROCEDURES A licensed physician investigator explains the nature of the study and requests consent from the childs primary caregiver or legal guardian as soon as possible after hospital admission Once consent is given the research coordinator obtains the baseline data
Ninety children will be enrolled in the study These children must a be a burn patient between the ages of 6 and 20 or an injured patient between the ages of 6-17 b have responded to the burn injury or surgery with fear helplessness or horror and c be proficient in English or Spanish If a child has no memory of the injury currently uses antidepressants or has a known sensitivity to sertraline diagnosis of Bipolar disorder diagnosis of PTSD mental retardation Traumatic Brain Injury or a new onset of seizures or marked worsening of a seizure disorder heshe will not be included in the study
STUDY PROCEDURES After the child is enrolled heshe is randomly assigned to receive either sertraline or placebo Neither the family nor the investigator will know which group the child is assigned to If at any time this information becomes medically necessary it will be made available to the childs doctor
The child takes the study medication every day for 12 weeks If the child is in the sertraline group the dose of medication may be increased gradually until a satisfactory response is achieved If the child is in the placebo group heshe may receive sertraline after 12 weeks if clinically indicated After 12 weeks the medication or placebo will be tapered at a rate of 25 mg every three days
All children and families are assessed at six points Early in their acute hospitalization Baseline at again at weeks 2 4 8 12 and 24 The baseline and follow-up assessments of 8 12 and 24 weeks include child and parent interviews During each assessment the child and parent complete several questionnaires examining how the child is functioning Check up assessments are completed as recommended by the FDA The assessments take place in the hospital at home or by the telephone after the child had been discharged
EQUITABLE SELECTION OF SUBJECTS Proficiency in English or Spanish is needed in order to be included in the study as the study instruments are not validated for non-English and non-Spanish speaking populations
PRIVACY AND CONFIDENTIALITY Parentsguardians are informed that the information gathered in the study is confidential and will not adversely affect their childs treatment in any way The child is assigned a research identification number and this number not their name will be placed on the study questionnaires The document that matches name with identification number is kept in a locked cabinet that is accessible only to study staff The data stored in the computer is password protected and computer access is limited to study staff All interview and questionnaire data is kept in a locked cabinet Families are also told prior to entering the study that certain information ie suspicions of child abuse or neglect cannot be confidential
EXPECTED BENEFITS The childs psychiatric symptoms may potentially decrease as a result of taking sertraline If sertraline is found to prevent PTSD the patient and other children will benefit from its use In addition the child may benefit from on-going psychological follow-up over the course of 24-weeks At the conclusion of the study the family has an opportunity to meet with one of the investigators and discuss the results of the evaluation
Potential benefits to society This study may be helpful in scientifically understanding the effect of sertraline on childrens psychological and physiological responses to stress It may be satisfying to families to learn that they are contributing to a body of knowledge that may help childrenadolescents who are burned or injured in other ways It is our hope that sertraline will help to prevent the debilitating symptoms of PTSD among burned and injured children and adolescents Because PTSD can have long-lasting impacts both on the developing brain as well as on functional development the successful prevention of the development of these symptoms would have far-reaching beneficial implications for children suffering burn injuries as well as those suffering other forms of physical and psychological trauma
FORESEEABLE RISKS AND DISCOMFORTS Sertraline has been shown to be well tolerated by both children and adolescents Its side effects may include nausea headache stomach distress diarrhea dry mouth insomnia sexual dysfunction sleepiness dizziness tremor and fatigue Most side effects appear early in treatment and for about 10 of people it leads to stopping treatment After tapering off the sertraline these side effects will gradually stop also
Because drugs that affect the nervous system can affect judgment thinking or coordination subjects will be warned to be cautious about operating hazardous machinery including automobiles until there is reasonable certainty that subjects are not affected adversely by this drug treatment
We ask subjects to avoid alcoholic beverages during this study It is possible that the combination of alcohol and medication may cause unknown side effects Use of illegal drugs is prohibited
Stopping the medication abruptly may be dangerous hence we inform the subjects that a gradual decrease in medication dose will be necessary for medication discontinuation The risks of suddenly stopping the mediation include the possibility of nausea malaise muscle aches headaches mood changes and unusual sensations numbness and tingling Subjects should contact the investigator before discontinuing the medication
If the side effects of the medication are too uncomfortable and remain so the sertraline may be decreased or tapered and stopped and alternative treatments will be offered including counseling andor alternative medications If a subject remains distressed doctors are available to help for as long as the subject is in the hospital If after the subject leaves the hospital and needs more treatment the study doctors will refer himher to a mental health professional in the community If during this study the subject becomes distressed heshe will have the opportunity to call and be evaluated by study staff
Individuals with bipolar disorder manic-depressive illness cannot participate in the study because of the risk of inducing mania or hypomania with anti-depressants
Due to potential for fatal interaction subjects should avoid taking monoamine oxidase inhibitors MAOIs within at least 30 days of taking sertraline and should avoid starting MAOI treatment until at least 30 days after discontinuation of treatment with sertraline
Subjects may experience an allergic reaction to sertraline or placebo ingredients If a subject experiences allergy symptoms such as rash hives or itching heshe should notify their doctor immediately Untreated allergy symptoms can lead to a medical emergency Since this is a research study and the treatments or procedures are relatively new there may be additional risks or side effects that we do not know about at this time but which might occur during the study or later Subjects will be informed of any significant new information regarding sertraline that may affect their willingness to continue participation in the study If subjects plan to take any drug other than the study medication or undergo any medical treatment then we ask them to notify the study doctor before starting the drug or treatment This applies to prescription drugs over-the-counter drugs such as cough and cold remedies antacids investigational drugsprocedures and sleeping medications If surgery or a diagnostic procedure is planned then the study doctor has to be notified before the procedure is performed
Pregnant women and nursing mothers cannot participate in this study It is important that subjects avoid pregnancy throughout this study because the use of any drug during pregnancy has the potential to harm the embryo or the fetus We will instruct women of childbearing potential that they must reliably practice an approved form of birth control while participating in the study If a subject does become pregnant she must tell the study doctor immediately Her participation in the study may end and she may need counseling for her pregnancy If a subject becomes pregnant during the study or 15 days after her last dose of the medication and her pregnancy is carried to term the investigator will ask her permission to follow the course of her pregnancy and delivery as well as the condition of her newborn If a subject misses a period or thinks she might be pregnant during the study she must notify her study doctor immediately so that she can be withdrawn from the study
MINIMIZATION OF RISKS AND SAFETY MONITORING Source data is monitored by the co-investigators in the study Safety and outcomes monitoring are conducted in accord with the rules and regulations of the Massachusetts General Hospital Adverse events monitoring is conducted in accord with the policies and procedures of the Massachusetts General Hospital and reported to the Human Research Committee of the Massachusetts General Hospital in accord with Partners Human Research Committee Adverse Event Reporting Guidelines
1 SPECIFIC AIM 1 To assess the efficacy of sertraline in preventing posttraumatic stress disorder in children aged 6-20 after a burn injury or reconstructive surgery following a burn injury
2 SPECIFIC AIM 2 To assess the efficacy of sertraline in preventing co-morbid depression in children aged 6-20 after a burn injury or reconstructive surgery following a burn injury
BACKGROUND AND SIGNIFICANCE Prevention of posttraumatic stress symptoms is a priority in psychiatric practice today This is the first controlled study of any medication to prevent posttraumatic stress disorder PTSD in children and adolescents The purpose of the study is to use sertraline to prevent PTSD and co-morbid depression from developing in 6-20 year old children hospitalized with a burn injury or reconstructive surgery following a burn injury If this intervention is successful it will help to prevent psychiatric and developmental disorders in injured children as well as those who undergo reconstructive procedures While we have found no studies that have investigated the efficacy of sertraline in treating PTSD in children and adolescents research indicates that sertraline is effective in treating other anxiety disorders and depression in children and adolescents Research also indicates that sertraline is effective in treating PTSD in adults
RECRUITMENT PROCEDURES Families of children aged 6-20 admitted with an acute burn or for reconstructive surgery are contacted by study staff within 3 days of admission or when medically stable and asked to participate in the study In addition 6-17 year old patients admitted for an injury are asked to participate
CONSENT PROCEDURES A licensed physician investigator explains the nature of the study and requests consent from the childs primary caregiver or legal guardian as soon as possible after hospital admission Once consent is given the research coordinator obtains the baseline data
Ninety children will be enrolled in the study These children must a be a burn patient between the ages of 6 and 20 or an injured patient between the ages of 6-17 b have responded to the burn injury or surgery with fear helplessness or horror and c be proficient in English or Spanish If a child has no memory of the injury currently uses antidepressants or has a known sensitivity to sertraline diagnosis of Bipolar disorder diagnosis of PTSD mental retardation Traumatic Brain Injury or a new onset of seizures or marked worsening of a seizure disorder heshe will not be included in the study
STUDY PROCEDURES After the child is enrolled heshe is randomly assigned to receive either sertraline or placebo Neither the family nor the investigator will know which group the child is assigned to If at any time this information becomes medically necessary it will be made available to the childs doctor
The child takes the study medication every day for 12 weeks If the child is in the sertraline group the dose of medication may be increased gradually until a satisfactory response is achieved If the child is in the placebo group heshe may receive sertraline after 12 weeks if clinically indicated After 12 weeks the medication or placebo will be tapered at a rate of 25 mg every three days
All children and families are assessed at six points Early in their acute hospitalization Baseline at again at weeks 2 4 8 12 and 24 The baseline and follow-up assessments of 8 12 and 24 weeks include child and parent interviews During each assessment the child and parent complete several questionnaires examining how the child is functioning Check up assessments are completed as recommended by the FDA The assessments take place in the hospital at home or by the telephone after the child had been discharged
EQUITABLE SELECTION OF SUBJECTS Proficiency in English or Spanish is needed in order to be included in the study as the study instruments are not validated for non-English and non-Spanish speaking populations
PRIVACY AND CONFIDENTIALITY Parentsguardians are informed that the information gathered in the study is confidential and will not adversely affect their childs treatment in any way The child is assigned a research identification number and this number not their name will be placed on the study questionnaires The document that matches name with identification number is kept in a locked cabinet that is accessible only to study staff The data stored in the computer is password protected and computer access is limited to study staff All interview and questionnaire data is kept in a locked cabinet Families are also told prior to entering the study that certain information ie suspicions of child abuse or neglect cannot be confidential
EXPECTED BENEFITS The childs psychiatric symptoms may potentially decrease as a result of taking sertraline If sertraline is found to prevent PTSD the patient and other children will benefit from its use In addition the child may benefit from on-going psychological follow-up over the course of 24-weeks At the conclusion of the study the family has an opportunity to meet with one of the investigators and discuss the results of the evaluation
Potential benefits to society This study may be helpful in scientifically understanding the effect of sertraline on childrens psychological and physiological responses to stress It may be satisfying to families to learn that they are contributing to a body of knowledge that may help childrenadolescents who are burned or injured in other ways It is our hope that sertraline will help to prevent the debilitating symptoms of PTSD among burned and injured children and adolescents Because PTSD can have long-lasting impacts both on the developing brain as well as on functional development the successful prevention of the development of these symptoms would have far-reaching beneficial implications for children suffering burn injuries as well as those suffering other forms of physical and psychological trauma
FORESEEABLE RISKS AND DISCOMFORTS Sertraline has been shown to be well tolerated by both children and adolescents Its side effects may include nausea headache stomach distress diarrhea dry mouth insomnia sexual dysfunction sleepiness dizziness tremor and fatigue Most side effects appear early in treatment and for about 10 of people it leads to stopping treatment After tapering off the sertraline these side effects will gradually stop also
Because drugs that affect the nervous system can affect judgment thinking or coordination subjects will be warned to be cautious about operating hazardous machinery including automobiles until there is reasonable certainty that subjects are not affected adversely by this drug treatment
We ask subjects to avoid alcoholic beverages during this study It is possible that the combination of alcohol and medication may cause unknown side effects Use of illegal drugs is prohibited
Stopping the medication abruptly may be dangerous hence we inform the subjects that a gradual decrease in medication dose will be necessary for medication discontinuation The risks of suddenly stopping the mediation include the possibility of nausea malaise muscle aches headaches mood changes and unusual sensations numbness and tingling Subjects should contact the investigator before discontinuing the medication
If the side effects of the medication are too uncomfortable and remain so the sertraline may be decreased or tapered and stopped and alternative treatments will be offered including counseling andor alternative medications If a subject remains distressed doctors are available to help for as long as the subject is in the hospital If after the subject leaves the hospital and needs more treatment the study doctors will refer himher to a mental health professional in the community If during this study the subject becomes distressed heshe will have the opportunity to call and be evaluated by study staff
Individuals with bipolar disorder manic-depressive illness cannot participate in the study because of the risk of inducing mania or hypomania with anti-depressants
Due to potential for fatal interaction subjects should avoid taking monoamine oxidase inhibitors MAOIs within at least 30 days of taking sertraline and should avoid starting MAOI treatment until at least 30 days after discontinuation of treatment with sertraline
Subjects may experience an allergic reaction to sertraline or placebo ingredients If a subject experiences allergy symptoms such as rash hives or itching heshe should notify their doctor immediately Untreated allergy symptoms can lead to a medical emergency Since this is a research study and the treatments or procedures are relatively new there may be additional risks or side effects that we do not know about at this time but which might occur during the study or later Subjects will be informed of any significant new information regarding sertraline that may affect their willingness to continue participation in the study If subjects plan to take any drug other than the study medication or undergo any medical treatment then we ask them to notify the study doctor before starting the drug or treatment This applies to prescription drugs over-the-counter drugs such as cough and cold remedies antacids investigational drugsprocedures and sleeping medications If surgery or a diagnostic procedure is planned then the study doctor has to be notified before the procedure is performed
Pregnant women and nursing mothers cannot participate in this study It is important that subjects avoid pregnancy throughout this study because the use of any drug during pregnancy has the potential to harm the embryo or the fetus We will instruct women of childbearing potential that they must reliably practice an approved form of birth control while participating in the study If a subject does become pregnant she must tell the study doctor immediately Her participation in the study may end and she may need counseling for her pregnancy If a subject becomes pregnant during the study or 15 days after her last dose of the medication and her pregnancy is carried to term the investigator will ask her permission to follow the course of her pregnancy and delivery as well as the condition of her newborn If a subject misses a period or thinks she might be pregnant during the study she must notify her study doctor immediately so that she can be withdrawn from the study
MINIMIZATION OF RISKS AND SAFETY MONITORING Source data is monitored by the co-investigators in the study Safety and outcomes monitoring are conducted in accord with the rules and regulations of the Massachusetts General Hospital Adverse events monitoring is conducted in accord with the policies and procedures of the Massachusetts General Hospital and reported to the Human Research Committee of the Massachusetts General Hospital in accord with Partners Human Research Committee Adverse Event Reporting Guidelines
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol 2002P001521 MGH | OTHER | Partners Human Research Committee | None |
| SHC Grant No 8840 | OTHER_GRANT | None | None |