Posttraumatic Stress DisorderPhase 3AripipPTSDNCT00440713
Aripiprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms
A Phase 3 study testing Aripiprazole and Interpersonal Therapy in people with Posttraumatic Stress Disorder, run by Federal University of São Paulo.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Aripiprazole and Interpersonal Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of PTSD (after SCID-I application by a trained psychiatrist).
- Use of an effective contraceptive method when the subject is women with sexual activity and with risk of pregnancy.
Who cannot join
- Clinical diagnosis of schizophrenic, delusional, psychotic depression, schizoaffective, bipolar or borderline personality (after SCID-I application by the a trained psychiatrist).
- Clinical diagnosis of psychoactive substance dependence within 6-months before the study enrollment.
- To have decompensated medical diagnostics needing urgent treatment
- being pregnant.
- using psychoactive drugs.
About this study
Official title: Phase 3 Study of Aripriprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms
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
Read the 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 7.5mg 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 (56.3%) were married, eight (25%) single, and six (18.7%) were widowed or divorced. Their mean age was 38.41 (+/-10.97) years old, and the mean time since trauma happened was 50.87 (+/-77.21) months. Three (9.4%) patients have been victims of sexual abuse, four (12.5%) kidnapped, four (12.5%) held hostage in prison rebellion, 7 (21.88%) lost a close person to homicide, 8 (18.75%), suffered a homicide attempt.
Nine (28%) patients discontinued the treatment before the second assessment. Six (18.7%) 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 28.7 (+/- 12.7) higher compared to the completers 25 (+/- 11.2) showing a statistically significant difference (t=.2167 p<.02) The mean dose was 9.6 (+/-4.3) mg/day, with the dose range of 3.75 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 82.7 (+/- 23.1) and 51.4 (+/-31.4) 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 (t=.000002, p<.001 - Table and Graph 1).
When using a concept of 30% decrease at CAPS mean score from baseline as a response to treatment, 17 (53.1%) patients have a response, and when using a more restrictive concept of 50% decrease at CAPS mean score 13 (40.6%) patients responded to the treatment.
The mean BAI score at baseline was 31.7 (+/- 13.4) and at the end-point were 25.4 (+/-18.2) (t=.01, p<.05) The SAS mean index score at baseline was 2.4 (+/-.45) and on the endpoint 2.27 (+/- .57) (t=.033, p<.05). The SF-36 mean score at baseline was 76.6 (+/-14.11) and at baseline 94.01 (+/- 25.06) (t=.0006, p<.05). 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 26.06 (+/- 11.6) and at the end-point of 21.35 (+/-12.6), the difference wasn't statistically significant (t=.58, p<.05).
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Aripiprazole, Interpersonal Therapy
- Keywords
- Posttraumatic Stress Disorder, Depression, Anxiety, Efficacy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Interpersonal TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS (Clinician Administered Posttraumatic Scale) score (PTSD symptoms)
Secondary outcomes (7)
Beck Depression Inventory
Beck Anxiety Inventory
Social Adjustment Scale
Global Assessment Functioning
MOS SF-36, quality of life
Dropout
complete the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startJan 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Marcelo F Mello, M.D., Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440713
- Sponsor's protocol ID
- 01
- Acronym
- AripipPTSD
- Status last verified
- Feb 2007
- First submitted
- 22 Feb 2007
- Last updated
- 27 Feb 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Aripriprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms
- ClinicalTrials.gov ID
- NCT00440713
- Acronym / sponsor ID
- AripipPTSD / 01
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Depression, Anxiety, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Mar 2006
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 7.5mg 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 (56.3%) were married, eight (25%) single, and six (18.7%) were widowed or divorced. Their mean age was 38.41 (+/-10.97) years old, and the mean time since trauma happened was 50.87 (+/-77.21) months. Three (9.4%) patients have been victims of sexual abuse, four (12.5%) kidnapped, four (12.5%) held hostage in prison rebellion, 7 (21.88%) lost a close person to homicide, 8 (18.75%), suffered a homicide attempt.
Nine (28%) patients discontinued the treatment before the second assessment. Six (18.7%) 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 28.7 (+/- 12.7) higher compared to the completers 25 (+/- 11.2) showing a statistically significant difference (t=.2167 p<.02) The mean dose was 9.6 (+/-4.3) mg/day, with the dose range of 3.75 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 82.7 (+/- 23.1) and 51.4 (+/-31.4) 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 (t=.000002, p<.001 - Table and Graph 1).
When using a concept of 30% decrease at CAPS mean score from baseline as a response to treatment, 17 (53.1%) patients have a response, and when using a more restrictive concept of 50% decrease at CAPS mean score 13 (40.6%) patients responded to the treatment.
The mean BAI score at baseline was 31.7 (+/- 13.4) and at the end-point were 25.4 (+/-18.2) (t=.01, p<.05) The SAS mean index score at baseline was 2.4 (+/-.45) and on the endpoint 2.27 (+/- .57) (t=.033, p<.05). The SF-36 mean score at baseline was 76.6 (+/-14.11) and at baseline 94.01 (+/- 25.06) (t=.0006, p<.05). 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 26.06 (+/- 11.6) and at the end-point of 21.35 (+/-12.6), the difference wasn't statistically significant (t=.58, p<.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of PTSD (after SCID-I application by a trained psychiatrist).
- Use of an effective contraceptive method when the subject is women with sexual activity and with risk of pregnancy.
Key exclusion criteria (5 listed)
- Clinical diagnosis of schizophrenic, delusional, psychotic depression, schizoaffective, bipolar or borderline personality (after SCID-I application by the a trained psychiatrist).
- Clinical diagnosis of psychoactive substance dependence within 6-months before the study enrollment.
- To have decompensated medical diagnostics needing urgent treatment
- being pregnant.
- using psychoactive drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aripiprazole | Drug | – |
| Interpersonal Therapy | Behavioural | – |
Primary outcome
CAPS (Clinician Administered Posttraumatic Scale) score (PTSD symptoms)
7 secondary outcomes
Beck Depression Inventory
Beck Anxiety Inventory
Social Adjustment Scale
Global Assessment Functioning
MOS SF-36, quality of life
Dropout
complete the trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo F Mello, M.D. principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole and Interpersonal Therapy in people with Posttraumatic Stress Disorder, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAPS (Clinician Administered Posttraumatic Scale) score (PTSD symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2007.