Intermittent Explosive Disorder
Conditions
Keywords
Intermittent Explosive Disorder, AVP-786
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).
Detailed description
Eligible participants for this study must have a diagnosis of current IED. This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.
Interventions
DRUGAVP-786
oral capsules
DRUGPlacebo
oral capsules
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version * At least 3 IED days (at least 1 IED episode each day, as recorded by the participant) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator * Score ≥ 12 on the Life History of Aggression scale at screening * Score ≥ 6 on the Overt Aggression Scale - Modified Total Irritability at screening and baseline * Score ≥ 4 on the modified Clinical Global Impression of Severity for IED at screening and baseline
Exclusion criteria
* Diagnosis of major depressive disorder within 6 months of screening * Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 score ≥ 10 at screening * Met only the DSM-5 A2 criterion for IED * Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria) * Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score at Week 12 | Baseline; Week 12 | The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x 3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault within that category). The weighted individual item scores are added to obtain the OAS-M Total Aggression score. Higher scores indicate increased aggression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the OAS-M Individual Items for Irritability at Week 12 | Baseline; Week 12 | The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M irritability domain includes 2 items: global subjective irritability and global overt irritability. Each response is scored using a 6-point scale (0 = not at all; 5 = extreme). Higher scores indicate increased irritability. |
| Change From Baseline in the Number of Intermittent Explosive Disorder (IED) Days Documented by Participants at Week 12 | Baseline; Week 12 | The IED episodes were to be documented by the participants each evening before bedtime. |
| Change From Baseline in the Number of IED Days as Assessed by the Investigator at Week 12 | Baseline; Week 12 | The IED episodes were to be documented by the participants each evening before bedtime and reviewed by the Investigator post dose. |
| Change From Baseline in the Number of IED Episodes at Week 12 | Baseline; Week 12 | The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes. |
| Change From Baseline in the Severity of IED Episodes at Week 12 | Baseline; Week 12 | The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes and to rate the severity of the worst episode (0 = not severe at all to 10 = worst severity imaginable). |
| Change From Baseline in the Severity of Distress From Episodes at Week 12 | Baseline; Week 12 | The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes and to rate the severity of distress experienced by the episode(s) (0 = no distress to 10 = worst distress imaginable). |
| Change From Baseline in the OAS-M: Number of Discrete IED Episodes at Week 12 | Baseline; Week 12 | The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression, and irritability. The OAS-M includes information regarding the number of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) A1 aggressive episodes, and the number of DSM-5 A2 aggressive episodes experienced by the participants during the past week. The number of discrete IED episodes is calculated after an interview with the participant. Episodes identified as discrete are separated by at least 30 minutes; episodes separated by less than 30 minutes are considered a single episode. |
| Change From Baseline in the OAS-M Individual Items for Aggression at Week 12 | Baseline; Week 12 | The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault). Higher scores indicate increased aggression. |
| Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12 | Baseline; Week 12 | The mCGI-C is a modified version of the CGI-C scale. The clinician rates the overall global change in the participant's IED symptoms (e.g., aggression, anger, and irritability) from Baseline at the scheduled double- blind visits. The mCGI-C responses are scored using a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse). |
| Change From Baseline in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED at Week 12 | Baseline; Week 12 | The mPGI-S is a single-question scale. Participants rate the overall global severity of their IED symptoms (e.g., aggression, anger, and irritability) using a 7-point scale (1 = normal, no symptoms; 2 = borderline symptoms; 3 = mild symptoms; 4 = moderately bad symptoms; 5 = markedly bad symptoms; 6 = severely bad symptoms; 7 = extremely bad symptoms). |
| Change From Baseline in the Modified Patient Global Impression of Change (mPGI-C) Score for IED at Week 12 | Baseline; Week 12 | The mPGI-C is a single-question scale. Participants rate the overall global change in their IED symptoms (e.g., aggression, anger, and irritability) from Baseline at the scheduled double-blind visits. The mPGI- C responses are scored using a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse). |
| Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12 | Baseline; Week 12 | The SDS is a 3-item, participant-rated questionnaire used to evaluate impairments in the domains of work/school, social life or leisure activities, and family life or home responsibility. Participants rate the degree of impairment in work/school, social life or leisure activities, and family life or home responsibility as a result of IED symptoms using a visual analogue scale (0 = no impairment; 1, 2, 3 = mildly; 4, 5, 6 = moderately; 7, 8, 9 = markedly; 10 = extremely). Only those score categories with at least one participant with event are reported. |
| Change From Baseline in the Short-Form 12-Item Health Survey (SF-12) Score at Week 12 | Baseline; Week 12 | The SF-12 is a 12-item, participant self-rated questionnaire used to measure the general health status and quality of life. The SF-12 includes questions to measure the effects of health on physical functioning, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores range from 0 to 100. Higher scores indicate better health status. |
| Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Baseline; Week 12 | The STAXI-2 is a 57-item, participant self-rated scale used to measure the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). The STAXI-2 includes a measure of state anger, trait anger, anger expression-out, anger expression-in, anger control-out and anger control, and the anger expression index (an overall measure of the expression and control of anger). The state anger items are scored using a 4-point scale (1 = not at all to 4 = very much so) to assess the intensity of anger feelings at a particular moment. The other scales are scored using a 4- point scale to assess how frequently angry feelings are experienced, expressed, suppressed, or controlled (1 = almost never to 4 = almost always). |
| Change From Baseline in the OAS-M Total Irritability Score at Week 12 | Baseline; Week 12 | The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression, and irritability. The OAS-M irritability domain includes 2 global assessment items: global subjective irritability and global overt irritability. Each response is scored using a 6-point scale (0 = not at all to 5 = extreme). The 2 scores are added to create the OAS-M Total Irritability score (range = 0 to 10). Higher scores indicate increased irritability. |
| Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12 | Baseline; Week 12 | The mCGI-S is a modified version of the CGI-S scale that provides a global evaluation of the participant's IED symptoms (e.g., aggression, anger, and irritability). The mCGI-S scale measures the severity of the participant's symptoms from the clinician's perspective in the context of other participants with IED. The mCGI-S responses are scored on a 7- point scale (1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants). |
Countries
United States
Participant flow
Pre-assignment details
A total of 37 participants were screened; 27 participants were screen failures, and 10 were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| AVP-786 Participants received AVP-786-28 (deudextromethorphan hydrobromide \[d6-DM\] 28 milligrams \[mg\]/quinidine sulfate \[Q\] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants received AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks. | 8 |
| Placebo Participants received placebo BID for 12 weeks. | 2 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | AVP-786 |
|---|---|---|---|
| Age, Continuous | NA years | NA years | NA years |
| Race (NIH/OMB) American Indian or Alaska Native | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Asian | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Black or African American | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Unknown or Not Reported | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) White | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 2 |
| other Total, other adverse events | 4 / 8 | 2 / 2 |
| serious Total, serious adverse events | 0 / 8 | 0 / 2 |
Outcome results
Primary
Change From Baseline in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x 3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault within that category). The weighted individual item scores are added to obtain the OAS-M Total Aggression score. Higher scores indicate increased aggression.
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
Secondary
Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12
The mCGI-C is a modified version of the CGI-C scale. The clinician rates the overall global change in the participant's IED symptoms (e.g., aggression, anger, and irritability) from Baseline at the scheduled double- blind visits. The mCGI-C responses are scored using a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse).
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12 | No Change | — |
| Unknown | Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12 | Minimally Improved | — |
| Unknown | Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12 | Much Improved | — |
| Unknown | Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12 | Very Much Improved | — |
Secondary
Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12
The mCGI-S is a modified version of the CGI-S scale that provides a global evaluation of the participant's IED symptoms (e.g., aggression, anger, and irritability). The mCGI-S scale measures the severity of the participant's symptoms from the clinician's perspective in the context of other participants with IED. The mCGI-S responses are scored on a 7- point scale (1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants).
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12 | Borderline Ill | — |
| Unknown | Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12 | Normal, Not at all Ill | — |
| Unknown | Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12 | Mildly Ill | — |
| Unknown | Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12 | Moderately Ill | — |
Secondary
Change From Baseline in the Modified Patient Global Impression of Change (mPGI-C) Score for IED at Week 12
The mPGI-C is a single-question scale. Participants rate the overall global change in their IED symptoms (e.g., aggression, anger, and irritability) from Baseline at the scheduled double-blind visits. The mPGI- C responses are scored using a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse).
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in the Modified Patient Global Impression of Change (mPGI-C) Score for IED at Week 12 | Minimally Improved | — |
| Unknown | Change From Baseline in the Modified Patient Global Impression of Change (mPGI-C) Score for IED at Week 12 | Much Improved | — |
| Unknown | Change From Baseline in the Modified Patient Global Impression of Change (mPGI-C) Score for IED at Week 12 | Very Much Improved | — |
Secondary
Change From Baseline in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED at Week 12
The mPGI-S is a single-question scale. Participants rate the overall global severity of their IED symptoms (e.g., aggression, anger, and irritability) using a 7-point scale (1 = normal, no symptoms; 2 = borderline symptoms; 3 = mild symptoms; 4 = moderately bad symptoms; 5 = markedly bad symptoms; 6 = severely bad symptoms; 7 = extremely bad symptoms).
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED at Week 12 | Normal, Not at All Ill | — |
| Unknown | Change From Baseline in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED at Week 12 | Borderline Ill | — |
| Unknown | Change From Baseline in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED at Week 12 | Mildly Ill | — |
Secondary
Change From Baseline in the Number of IED Days as Assessed by the Investigator at Week 12
The IED episodes were to be documented by the participants each evening before bedtime and reviewed by the Investigator post dose.
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
Secondary
Change From Baseline in the Number of IED Episodes at Week 12
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes.
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned..
Secondary
Change From Baseline in the Number of Intermittent Explosive Disorder (IED) Days Documented by Participants at Week 12
The IED episodes were to be documented by the participants each evening before bedtime.
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
Secondary
Change From Baseline in the OAS-M Individual Items for Aggression at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault). Higher scores indicate increased aggression.
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
Secondary
Change From Baseline in the OAS-M Individual Items for Irritability at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M irritability domain includes 2 items: global subjective irritability and global overt irritability. Each response is scored using a 6-point scale (0 = not at all; 5 = extreme). Higher scores indicate increased irritability.
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
Secondary
Change From Baseline in the OAS-M: Number of Discrete IED Episodes at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression, and irritability. The OAS-M includes information regarding the number of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) A1 aggressive episodes, and the number of DSM-5 A2 aggressive episodes experienced by the participants during the past week. The number of discrete IED episodes is calculated after an interview with the participant. Episodes identified as discrete are separated by at least 30 minutes; episodes separated by less than 30 minutes are considered a single episode.
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
Secondary
Change From Baseline in the OAS-M Total Irritability Score at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression, and irritability. The OAS-M irritability domain includes 2 global assessment items: global subjective irritability and global overt irritability. Each response is scored using a 6-point scale (0 = not at all to 5 = extreme). The 2 scores are added to create the OAS-M Total Irritability score (range = 0 to 10). Higher scores indicate increased irritability.
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
Secondary
Change From Baseline in the Severity of Distress From Episodes at Week 12
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes and to rate the severity of distress experienced by the episode(s) (0 = no distress to 10 = worst distress imaginable).
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in the Severity of Distress From Episodes at Week 12 | Severity Distress Grade 2 | — |
| Unknown | Change From Baseline in the Severity of Distress From Episodes at Week 12 | Severity Distress Grade 3 | — |
| Unknown | Change From Baseline in the Severity of Distress From Episodes at Week 12 | Severity Distress Grade 4 | — |
Secondary
Change From Baseline in the Severity of IED Episodes at Week 12
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes and to rate the severity of the worst episode (0 = not severe at all to 10 = worst severity imaginable).
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in the Severity of IED Episodes at Week 12 | Severity Grade 3 | — |
| Unknown | Change From Baseline in the Severity of IED Episodes at Week 12 | Severity Grade 4 | — |
Secondary
Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12
The SDS is a 3-item, participant-rated questionnaire used to evaluate impairments in the domains of work/school, social life or leisure activities, and family life or home responsibility. Participants rate the degree of impairment in work/school, social life or leisure activities, and family life or home responsibility as a result of IED symptoms using a visual analogue scale (0 = no impairment; 1, 2, 3 = mildly; 4, 5, 6 = moderately; 7, 8, 9 = markedly; 10 = extremely). Only those score categories with at least one participant with event are reported.
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12 | SDS01- Work/School: Not at All | — |
| Unknown | Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12 | SDS01- Work/School: Mildly | — |
| Unknown | Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12 | SDS01- No Work/Study - Unrelated Disorder: Yes | — |
| Unknown | Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12 | SDS01- Social Life: Not at All | — |
| Unknown | Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12 | SDS01- Social Life: Moderately | — |
| Unknown | Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12 | SDS01- Social Life: Mildly | — |
| Unknown | Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12 | SDS01- Family Life/Home Responsibilities: Mildly | — |
Secondary
Change From Baseline in the Short-Form 12-Item Health Survey (SF-12) Score at Week 12
The SF-12 is a 12-item, participant self-rated questionnaire used to measure the general health status and quality of life. The SF-12 includes questions to measure the effects of health on physical functioning, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores range from 0 to 100. Higher scores indicate better health status.
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in the Short-Form 12-Item Health Survey (SF-12) Score at Week 12 | SDS01- Days Lost | — |
| Unknown | Change From Baseline in the Short-Form 12-Item Health Survey (SF-12) Score at Week 12 | SDS01- Days Underproductive | — |
Secondary
Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12
The STAXI-2 is a 57-item, participant self-rated scale used to measure the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). The STAXI-2 includes a measure of state anger, trait anger, anger expression-out, anger expression-in, anger control-out and anger control, and the anger expression index (an overall measure of the expression and control of anger). The state anger items are scored using a 4-point scale (1 = not at all to 4 = very much so) to assess the intensity of anger feelings at a particular moment. The other scales are scored using a 4- point scale to assess how frequently angry feelings are experienced, expressed, suppressed, or controlled (1 = almost never to 4 = almost always).
Time frame: Baseline; Week 12
Population: As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am furious: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am furious: Somewhat | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel irritated: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel irritated: Somewhat | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel angry: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel angry: Somewhat | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel angry: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like yelling at somebody: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like yelling at somebody: Somewhat | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like yelling at somebody: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like breaking things: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like breaking things: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am mad: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am mad: Somewhat | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am mad: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like banging on the table: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like banging on the table: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like hitting someone: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like hitting someone: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like swearing: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like swearing: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel annoyed: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel annoyed: Somewhat | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel annoyed: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like kicking somebody: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like kicking somebody: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like cursing out loud: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like cursing out loud: Somewhat | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like cursing out loud: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like screaming: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like screaming: Somewhat | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like screaming: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like pounding somebody: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like pounding somebody: Somewhat | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like pounding somebody: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like shouting out loud: Not at all | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like shouting out loud: Somewhat | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I feel like shouting out loud: Very Much so | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am quick tempered: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am quick tempered: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am quick tempered: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I have a fiery temper: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I have a fiery temper: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I have a fiery temper: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am a hotheaded person: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am a hotheaded person: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am a hotheaded person: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am a hotheaded person: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Angry when slowed down by others' error: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Angry when slowed down by others' error: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Angry when slowed down by others' error: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Annoyed if not recognized for good work: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Annoyed if not recognized for good work: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Annoyed if not recognized for good work: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I fly off the handle: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I fly off the handle: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I fly off the handle: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I fly off the handle: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | When I get mad, I say nasty things: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | When I get mad, I say nasty things: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | When I get mad, I say nasty things: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Furious criticized in front of others: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Furious criticized in front of others: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Furious criticized in front of others: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Furious criticized in front of others: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | When frustrated, I feel like hitting: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | When frustrated, I feel like hitting: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | When frustrated, I feel like hitting: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Frustrated when good job gets bad: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Frustrated when good job gets bad: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Frustrated when good job gets bad: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I control my temper: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I control my temper: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I control my temper: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I express my anger: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I express my anger: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I express my anger: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I take a deep breath and relax: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I take a deep breath and relax: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I take a deep breath and relax: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I keep things in: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I keep things in: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I keep things in: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am patient with others: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am patient with others: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | If annoyed, I'm apt to say how I feel: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | If annoyed, I'm apt to say how I feel: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | If annoyed, I'm apt to say how I feel: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to calm myself as soon as possible: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to calm myself as soon as possible: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to calm myself as soon as possible: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I pout or sulk: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I pout or sulk: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I pout or sulk: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I control urge to express angry feelings: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I control urge to express angry feelings: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I control urge to express angry feelings: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I lose my temper: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I lose my temper: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I lose my temper: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to simmer down: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to simmer down: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I withdraw from people: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I withdraw from people: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I withdraw from people: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I withdraw from people: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I keep my cool: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I keep my cool: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I make sarcastic remarks to others: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I make sarcastic remarks to others: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I make sarcastic remarks to others: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I make sarcastic remarks to others: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to sooth my angry feelings: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I boil inside, but I don't show it: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I boil inside, but I don't show it: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I boil inside, but I don't show it: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I control my behavior: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I control my behavior: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I control my behavior: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I do things like slam doors: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I do things like slam doors: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I do things like slam doors: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I endeavor to become calm again: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I endeavor to become calm again: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Grudges I don't tell anyone about: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Grudges I don't tell anyone about: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Grudges I don't tell anyone about: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Grudges I don't tell anyone about: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I can stop myself from losing my temper: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I can stop myself from losing my temper: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I can stop myself from losing my temper: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I argue with others: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I argue with others: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I argue with others: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I reduce my anger as soon as possible: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I reduce my anger as soon as possible: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I reduce my anger as soon as possible: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am secretly quite critical of others: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am secretly quite critical of others: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am secretly quite critical of others: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am secretly quite critical of others: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to be tolerant and understanding: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to be tolerant and understanding: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to be tolerant and understanding: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to be tolerant and understanding: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I strike out at whatever infuriates me: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I strike out at whatever infuriates me: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I strike out at whatever infuriates me: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I strike out at whatever infuriates me: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I do something relaxing to calm down: | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I do something relaxing to calm down: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I do something relaxing to calm down: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am angrier than I am willing to admit: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am angrier than I am willing to admit: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am angrier than I am willing to admit: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I am angrier than I am willing to admit: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I control my angry feelings: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I control my angry feelings: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I say nasty things: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I say nasty things: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I say nasty things: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I say nasty things: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to relax: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | I try to relax: Sometimes | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Irritated more than people are aware of: Almost Always | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Irritated more than people are aware of: Often | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Irritated more than people are aware of: Almost Never | — |
| Unknown | Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12 | Irritated more than people are aware of: Sometimes | — |