Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440713
Status:
COMPLETED
Last Update Posted:
2007-02-27
First Post:
2007-02-22
Brief Title:
Aripiprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Phase 3 Study of Aripriprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms
Status:
COMPLETED
Status Verified Date:
2007-02
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:
AripipPTSD
Brief Summary:
32 outpatients with a Posttraumatic Stress Disorder were included in a randomized comparative single-blind study to study the efficacy of aripiprazole to treat post-traumatic stress symptoms
The hypothesis is that aripiprazole has an efficacy to reduce PTSD symptoms
The hypothesis is that aripiprazole has an efficacy to reduce PTSD symptoms
Detailed Description:
All patients which agreed to participate and signed the informed consent were interviewed to be enrolled if they filled the inclusion and exclusion criteria
The inclusion criteria were both genders aged 18 to 60 diagnosis of PTSD DSM-IV criteria by a trained psychiatrist after the application of the SCID-I Women must be using contraceptive methods during the study Women had to be using contraceptive methods during the study The exclusion criteria were to have a diagnostic of the following conditions schizophrenic disorder delusional disorder bipolar disorder psychotic depression episode and psychoactive substance dependency disorder in the previous 6-month period instable medical diseases and pregnancy
All included patient was submitted at baseline to a socio-demographic inventory and to a psychometric evaluation the latter were reapplied at weeks 8 and 16 The psychometric evaluation consist of self-report instruments CAPS to measure PTSD symptoms severity the Beck Depression Inventory BDI 29 and the Beck Anxiety Inventory BAI 30 to measure the depressive and the anxiety symptoms severity the Medical Outcome Scale short form MOS-SF-36 31 and the Social adjustment scale SAS 32 to evaluate quality of life and social adjustment A 75mg single dose of aripiprazole was prescribed and the patient was evaluated each two weeks and dose could be increased or decreased depending of their tolerability to side effects After 16-week the drug was discontinued over a two week period
Thirty-two outpatients were included after filling the inclusion and exclusion criteria Twenty-four 75 were women and 8 25 men Eighteen 563 were married eight 25 single and six 187 were widowed or divorced Their mean age was 3841 -1097 years old and the mean time since trauma happened was 5087 -7721 months Three 94 patients have been victims of sexual abuse four 125 kidnapped four 125 held hostage in prison rebellion 7 2188 lost a close person to homicide 8 1875 suffered a homicide attempt
Nine 28 patients discontinued the treatment before the second assessment Six 187 patients discontinued the medication because of adverse events anxiety psychomotor agitation nausea and insomnia three 3 patients abandoned the treatment and we lost contact with them Six 6 patients had at least a second assessment but did not complete 16-week trial three due to a complete remission and a resistance to continue on the study and three discontinued due to lack of clinical improvement The BDI baseline mean score from the dropouters was 287 - 127 higher compared to the completers 25 - 112 showing a statistically significant difference t2167 p02 The mean dose was 96 -43 mgday with the dose range of 375 to 15 mg day
An intention-to-treat analysis using the Last Observation Carried Forward LOCF including the baseline outcome data found a CAPS mean score at baseline of 827 - 231 and 514 -314 on endpoint over 38 reduction from the baseline Comparing the data using the t test the difference between before and after the treatment was statistically significant t000002 p001 - Table and Graph 1
When using a concept of 30 decrease at CAPS mean score from baseline as a response to treatment 17 531 patients have a response and when using a more restrictive concept of 50 decrease at CAPS mean score 13 406 patients responded to the treatment
The mean BAI score at baseline was 317 - 134 and at the end-point were 254 -182 t01 p05 The SAS mean index score at baseline was 24 -45 and on the endpoint 227 - 57 t033 p05 The SF-36 mean score at baseline was 766 -1411 and at baseline 9401 - 2506 t0006 p05 On all measures excepted on BDI the differences between baseline and endpoint means were statistically significant On the BDI with a mean score at baseline of 2606 - 116 and at the end-point of 2135 -126 the difference wasnt statistically significant t58 p05
The inclusion criteria were both genders aged 18 to 60 diagnosis of PTSD DSM-IV criteria by a trained psychiatrist after the application of the SCID-I Women must be using contraceptive methods during the study Women had to be using contraceptive methods during the study The exclusion criteria were to have a diagnostic of the following conditions schizophrenic disorder delusional disorder bipolar disorder psychotic depression episode and psychoactive substance dependency disorder in the previous 6-month period instable medical diseases and pregnancy
All included patient was submitted at baseline to a socio-demographic inventory and to a psychometric evaluation the latter were reapplied at weeks 8 and 16 The psychometric evaluation consist of self-report instruments CAPS to measure PTSD symptoms severity the Beck Depression Inventory BDI 29 and the Beck Anxiety Inventory BAI 30 to measure the depressive and the anxiety symptoms severity the Medical Outcome Scale short form MOS-SF-36 31 and the Social adjustment scale SAS 32 to evaluate quality of life and social adjustment A 75mg single dose of aripiprazole was prescribed and the patient was evaluated each two weeks and dose could be increased or decreased depending of their tolerability to side effects After 16-week the drug was discontinued over a two week period
Thirty-two outpatients were included after filling the inclusion and exclusion criteria Twenty-four 75 were women and 8 25 men Eighteen 563 were married eight 25 single and six 187 were widowed or divorced Their mean age was 3841 -1097 years old and the mean time since trauma happened was 5087 -7721 months Three 94 patients have been victims of sexual abuse four 125 kidnapped four 125 held hostage in prison rebellion 7 2188 lost a close person to homicide 8 1875 suffered a homicide attempt
Nine 28 patients discontinued the treatment before the second assessment Six 187 patients discontinued the medication because of adverse events anxiety psychomotor agitation nausea and insomnia three 3 patients abandoned the treatment and we lost contact with them Six 6 patients had at least a second assessment but did not complete 16-week trial three due to a complete remission and a resistance to continue on the study and three discontinued due to lack of clinical improvement The BDI baseline mean score from the dropouters was 287 - 127 higher compared to the completers 25 - 112 showing a statistically significant difference t2167 p02 The mean dose was 96 -43 mgday with the dose range of 375 to 15 mg day
An intention-to-treat analysis using the Last Observation Carried Forward LOCF including the baseline outcome data found a CAPS mean score at baseline of 827 - 231 and 514 -314 on endpoint over 38 reduction from the baseline Comparing the data using the t test the difference between before and after the treatment was statistically significant t000002 p001 - Table and Graph 1
When using a concept of 30 decrease at CAPS mean score from baseline as a response to treatment 17 531 patients have a response and when using a more restrictive concept of 50 decrease at CAPS mean score 13 406 patients responded to the treatment
The mean BAI score at baseline was 317 - 134 and at the end-point were 254 -182 t01 p05 The SAS mean index score at baseline was 24 -45 and on the endpoint 227 - 57 t033 p05 The SF-36 mean score at baseline was 766 -1411 and at baseline 9401 - 2506 t0006 p05 On all measures excepted on BDI the differences between baseline and endpoint means were statistically significant On the BDI with a mean score at baseline of 2606 - 116 and at the end-point of 2135 -126 the difference wasnt statistically significant t58 p05
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