Combat Disorders, Stress Disorders, Post-Traumatic
Conditions
Keywords
Atypical Antipsychotics, Controlled Trial, Paroxetine, Quetiapine, Stress Disorders, Post-Traumatic, Treatment refractory, Treatment resistant
Brief summary
The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo.
Detailed description
This is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to paroxetine treatment. In Phase I, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8 weeks. Patients who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for the second phase. In Phase II, patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) or placebo for 8 weeks in a double-blind fashion.
Interventions
DRUGOpen Label (OL) Paroxetine
Open-label Paroxetine
DRUGPlacebo
Double-blind placebo taken with OL paroxetine
DRUGQuetiapine
Double-blind quetiapine taken with OL paroxetine
Sponsors
AstraZeneca
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Veteran age 18 to 75. * Competent to give informed consent. * Meeting DSM-IV criteria for PTSD. * Minimal CAPS score of 50 at baseline. * If female of childbearing potential, patient must have a negative pregnancy test and, if sexually active, be using a medically approved contraceptive method. * Patients who have not taken psychiatric medications within 1 week prior to study entry (except fluoxetine \[5 weeks\]) * monoamine oxidase inhibitors (MAOIs \[4 weeks\]) * depot neuroleptics \[4 weeks\]) * or any investigational drug within 30 days prior to study enrollment. * To be eligible for Phase II * patients must be refractory to paroxetine in Phase I, as defined by less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8 * must have PTSD symptoms at least moderate severity on CGI-S * and must have been compliant with study medicine in Phase I, as defined by taking at least 80% of prescribed doses.
Exclusion criteria
* History of sensitivity to paroxetine or quetiapine. * Failure to respond to a prior adequate therapeutic trial i.e. minimum of 8 weeks at maximum tolerated dose of paroxetine (up to 60 mg daily) or quetiapine (up to 800 mg daily). * Women who are * breast-feeding * pregnant * expect to become pregnant during the course of the study * or are sexually active and are not using a medically acceptable method of birth control. * Presence of clinically significant hepatic * cardiovascular * or other medical conditions that may prevent safe administration of paroxetine or quetiapine * or any other clinically significant unstable medical conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. | From baseline (week 8) to endpoint (week 16 or termination) | The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean PANSS Total and Subscores From Baseline to Endpoint | Baseline (week 8) to Endpoint (week 16 or termination) | Positive and Negative Symptom Scale (PANSS). A 30-item clinician administered rating scale for which positive, negative and general subscales are scored from 30 to 210 with a higher scores indicating greater severity of symptoms. |
| Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores | From Baseline (week 8) to Endpoint (week 16 or Termination) | Hamilton Rating Scale for Depression (HAMD) was used as a measure of depression. Scoring is based on a 17-item scale. Eight items are scored on a 5 point scale from 0= not present to 4= severe. The scoring is based on the first 17 items. Scores of 0-7 normal, 8-13 is mild depression, 14-18 moderate depression, 19-22 severe depression and 23 and above very severe depression; the maximum score being 52 on the 17-point scale. |
| Change in Total Mean Davidson Trauma Scale (DTS) | From Baseline (week 8) to Endpoint (week 16 or Termination) | The DTS is a 17-item self-rated scale that measures the frequency and the severity of DSM-IV PTSD symptoms. Items are rated on 5-point frequency (0 = not at all to 4 = every day) and severity scales (0 = not at all distressing to 4 = extremely distressing). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). A higher score indicates higher frequency and severity. It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters (i.e., B, C, and D). |
| Change in CGI-I | From Baseline (week 8) to Endpoint (week 16 or termination) | Clinical Global Impressions Scale and Global Improvement Subscales (CGI-I) is a 7-point scale which was used to assess overall improvement. The scores range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse. |
| Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint. | From Baseline (week 8) to Endpoint (week 16) | The PSQI is one of the most frequently used self-rated sleep questionnaire. Total score ranging from 0 to 21. Higher scores are representing worse sleep quality. |
| Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Baseline (week 8) to Endpoint (week 16 or termination) | The SDS is a brief 3-item questionnaire that was used as a self-report to assess the degree to which psychiatric symptoms have disrupted the patient's work, family/home responsibilities, and social life. Score ranging from 0 (no impairment) to 30 (most severe). |
| Change in Arizona Sexual Experience Scale (ASEX) | From Baseline (week 8) to Endpoint (week 16 or termination) | The ASEX is a brief 5-item rating scale that assesses five global aspects of sexual dysfunction. Score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences. |
| Change in Mean Q-LES-Q Score From Baseline to Endpoint. | From Baseline (week 8) to Endpoint (week 16 or termination) | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) a self-rated 14-item questionnaire designed to assess the degree of enjoyment and satisfaction of various aspects of daily functioning. Each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. A lower score indicates worsening and a higher score indicates better quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1/Open-Label (OL) Paroxetine Phase I : Open-label Paroxetine
In Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II | 124 |
| Arm 2/OL Paroxetine & Double-blind Placebo Phase II: Double-blind placebo
In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion. | 25 |
| Arm 3/OL Paroxetine & Double-blind Quetiapine Phase II: Double-blind quetiapine
In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine in a double-blind fashion. | 25 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Phase II: OLP + DB Quetiapine or Placebo | Lost to Follow-up | 0 | 3 | 2 |
| Phase II: OLP + DB Quetiapine or Placebo | Withdrawal by Subject | 0 | 1 | 5 |
| Phase I - Open-Label Paroxetine (OLP) | Adverse Event | 12 | 0 | 0 |
| Phase I - Open-Label Paroxetine (OLP) | Lost to Follow-up | 22 | 0 | 0 |
| Phase I - Open-Label Paroxetine (OLP) | Physician Decision | 8 | 0 | 0 |
| Phase I - Open-Label Paroxetine (OLP) | Withdrawal by Subject | 4 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm 1/Open-Label (OL) Paroxetine | Arm 2/OL Paroxetine & Double-blind Placebo | Arm 3/OL Paroxetine & Double-blind Quetiapine | Total |
|---|---|---|---|---|
| Age, Customized Age - Double Blind | NA years | 57.17 years STANDARD_DEVIATION 8.74 | 54.45 years STANDARD_DEVIATION 13.69 | 54.76 years STANDARD_DEVIATION 11.48 |
| Age, Customized Age - OL Paroxetine | 52.32 years STANDARD_DEVIATION 13.23 | NA years | NA years | 52.32 years STANDARD_DEVIATION 13.23 |
| Race/Ethnicity, Customized DB African American | — | 15 Participants | 10 Participants | 25 Participants |
| Race/Ethnicity, Customized DB Amer Indian/ Alaska Native | — | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized DB Unknown/ Not Reported | — | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized DB White | — | 9 Participants | 14 Participants | 23 Participants |
| Race/Ethnicity, Customized OL African American | 50 Participants | — | — | 50 Participants |
| Race/Ethnicity, Customized OL Amer Indian/ Alask Native | 2 Participants | — | — | 2 Participants |
| Race/Ethnicity, Customized OL Unknown or Not Reported | 4 Participants | — | — | 4 Participants |
| Race/Ethnicity, Customized OL White | 68 Participants | — | — | 68 Participants |
| Region of Enrollment United States | 124 Participants | — | — | 124 Participants |
| Sex/Gender, Customized Females Double Blind | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Gender OL Females | 5 Participants | — | — | 5 Participants |
| Sex/Gender, Customized Gender OL Males | 119 Participants | — | — | 119 Participants |
| Sex/Gender, Customized Males Double Blind | 0 Participants | 24 Participants | 24 Participants | 48 Participants |
| Years of Education Education - Double Blind (DB), Phase II | NA years | 13.22 years STANDARD_DEVIATION 2.74 | 12.55 years STANDARD_DEVIATION 1.53 | 12.89 years STANDARD_DEVIATION 2.24 |
| Years of Education Education - Open Label (OL) Population | 13.12 years STANDARD_DEVIATION 2.05 | NA years | NA years | 13.12 years STANDARD_DEVIATION 2.05 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 23 / 124 | 2 / 25 | 8 / 25 |
| serious Total, serious adverse events | 5 / 124 | 0 / 25 | 2 / 25 |
Outcome results
Primary
Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.
The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change.
Time frame: From baseline (week 8) to endpoint (week 16 or termination)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 2 OL Paroxetine + DB Placebo | Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. | CAPS Total Baseline | 72.15 units on a scale | Standard Deviation 15.96 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. | CAPS Total Endpoint | 67.90 units on a scale | Standard Deviation 14.9 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. | CAPS Total Baseline | 68.78 units on a scale | Standard Deviation 17.01 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. | CAPS Total Endpoint | 51.52 units on a scale | Standard Deviation 19.68 |
p-value: <0.05Mixed Models Analysis
Secondary
Change in Arizona Sexual Experience Scale (ASEX)
The ASEX is a brief 5-item rating scale that assesses five global aspects of sexual dysfunction. Score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.
Time frame: From Baseline (week 8) to Endpoint (week 16 or termination)
Population: Randomized participants with an ASEX score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 2 OL Paroxetine + DB Placebo | Change in Arizona Sexual Experience Scale (ASEX) | Baseline ASEX | 22.00 units on a scale | Standard Deviation 6.68 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Arizona Sexual Experience Scale (ASEX) | Endpoint ASEX | 21.93 units on a scale | Standard Deviation 7.45 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Arizona Sexual Experience Scale (ASEX) | Baseline ASEX | 17.88 units on a scale | Standard Deviation 5.33 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Arizona Sexual Experience Scale (ASEX) | Endpoint ASEX | 16.94 units on a scale | Standard Deviation 5.84 |
Secondary
Change in CGI-I
Clinical Global Impressions Scale and Global Improvement Subscales (CGI-I) is a 7-point scale which was used to assess overall improvement. The scores range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse.
Time frame: From Baseline (week 8) to Endpoint (week 16 or termination)
Population: Randomized participants with CGI-I score
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 2 OL Paroxetine + DB Placebo | Change in CGI-I | Baseline CGI-I | 3.56 units on a scale | Standard Deviation 0.85 |
| Arm 2 OL Paroxetine + DB Placebo | Change in CGI-I | Endpoint CGI-I | 2.61 units on a scale | Standard Deviation 0.79 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in CGI-I | Baseline CGI-I | 3.36 units on a scale | Standard Deviation 0.88 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in CGI-I | Endpoint CGI-I | 2.22 units on a scale | Standard Deviation 1.19 |
Secondary
Change in Mean PANSS Total and Subscores From Baseline to Endpoint
Positive and Negative Symptom Scale (PANSS). A 30-item clinician administered rating scale for which positive, negative and general subscales are scored from 30 to 210 with a higher scores indicating greater severity of symptoms.
Time frame: Baseline (week 8) to Endpoint (week 16 or termination)
Population: Randomized participants with a PANSS score
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean PANSS Total and Subscores From Baseline to Endpoint | Endpoint Total PANSS | 43.92 units on a scale | Standard Deviation 6.81 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean PANSS Total and Subscores From Baseline to Endpoint | Baseline Total PANSS | 46.63 units on a scale | Standard Deviation 10.13 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean PANSS Total and Subscores From Baseline to Endpoint | Baseline Total PANSS | 47.76 units on a scale | Standard Deviation 11.09 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean PANSS Total and Subscores From Baseline to Endpoint | Endpoint Total PANSS | 42.24 units on a scale | Standard Deviation 8.07 |
Secondary
Change in Mean Q-LES-Q Score From Baseline to Endpoint.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) a self-rated 14-item questionnaire designed to assess the degree of enjoyment and satisfaction of various aspects of daily functioning. Each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. A lower score indicates worsening and a higher score indicates better quality of life.
Time frame: From Baseline (week 8) to Endpoint (week 16 or termination)
Population: Randomized participants with a Q-LES-Q score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean Q-LES-Q Score From Baseline to Endpoint. | Baseline Q-LES-Q | 37.85 units on a scale | Standard Deviation 7.78 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean Q-LES-Q Score From Baseline to Endpoint. | Endpoint Q-LES-Q | 38.22 units on a scale | Standard Deviation 6.62 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean Q-LES-Q Score From Baseline to Endpoint. | Baseline Q-LES-Q | 40.44 units on a scale | Standard Deviation 8.82 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean Q-LES-Q Score From Baseline to Endpoint. | Endpoint Q-LES-Q | 41.06 units on a scale | Standard Deviation 6.7 |
Secondary
Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint.
The PSQI is one of the most frequently used self-rated sleep questionnaire. Total score ranging from 0 to 21. Higher scores are representing worse sleep quality.
Time frame: From Baseline (week 8) to Endpoint (week 16)
Population: Randomized participants with a PSQI score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint. | Baseline PSQI | 11.60 units on a scale | Standard Deviation 3.93 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint. | Endpoint PSQI | 8.70 units on a scale | Standard Deviation 3.15 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint. | Baseline PSQI | 12.69 units on a scale | Standard Deviation 3.46 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint. | Endpoint PSQI | 13.19 units on a scale | Standard Deviation 2.88 |
Secondary
Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint.
The SDS is a brief 3-item questionnaire that was used as a self-report to assess the degree to which psychiatric symptoms have disrupted the patient's work, family/home responsibilities, and social life. Score ranging from 0 (no impairment) to 30 (most severe).
Time frame: Baseline (week 8) to Endpoint (week 16 or termination)
Population: Randomized participants with an SDS score
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Endpoint SDS-FL | 5.39 units on a scale | Standard Deviation 2.48 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Endpoint SDS-WS | 4.58 units on a scale | Standard Deviation 2.99 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Baseline SDS-FL | 5.85 units on a scale | Standard Deviation 2.92 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Baseline SDS-WS | 5.07 units on a scale | Standard Deviation 3.45 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Endpoint SDS-SL | 5.92 units on a scale | Standard Deviation 2.55 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Baseline SDS-SL | 6.67 units on a scale | Standard Deviation 2.44 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Endpoint SDS-SL | 4.95 units on a scale | Standard Deviation 1.83 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Baseline SDS-FL | 4.72 units on a scale | Standard Deviation 2.48 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Endpoint SDS-FL | 4.61 units on a scale | Standard Deviation 2.27 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Baseline SDS-WS | 4.44 units on a scale | Standard Deviation 2.95 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Endpoint SDS-WS | 4.66 units on a scale | Standard Deviation 2.34 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. | Baseline SDS-SL | 5.64 units on a scale | Standard Deviation 2.93 |
Secondary
Change in Total Mean Davidson Trauma Scale (DTS)
The DTS is a 17-item self-rated scale that measures the frequency and the severity of DSM-IV PTSD symptoms. Items are rated on 5-point frequency (0 = not at all to 4 = every day) and severity scales (0 = not at all distressing to 4 = extremely distressing). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). A higher score indicates higher frequency and severity. It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters (i.e., B, C, and D).
Time frame: From Baseline (week 8) to Endpoint (week 16 or Termination)
Population: Randomized participants with a DTS score
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 2 OL Paroxetine + DB Placebo | Change in Total Mean Davidson Trauma Scale (DTS) | Baseline DTS | 82.19 units on a scale | Standard Deviation 24.6 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Total Mean Davidson Trauma Scale (DTS) | Endpoint DTS | 84.06 units on a scale | Standard Deviation 21.92 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Total Mean Davidson Trauma Scale (DTS) | Baseline DTS | 77.25 units on a scale | Standard Deviation 25.94 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Total Mean Davidson Trauma Scale (DTS) | Endpoint DTS | 61.50 units on a scale | Standard Deviation 18.2 |
Secondary
Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores
Hamilton Rating Scale for Depression (HAMD) was used as a measure of depression. Scoring is based on a 17-item scale. Eight items are scored on a 5 point scale from 0= not present to 4= severe. The scoring is based on the first 17 items. Scores of 0-7 normal, 8-13 is mild depression, 14-18 moderate depression, 19-22 severe depression and 23 and above very severe depression; the maximum score being 52 on the 17-point scale.
Time frame: From Baseline (week 8) to Endpoint (week 16 or Termination)
Population: Randomized participants with a HAMD score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 2 OL Paroxetine + DB Placebo | Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores | Baseline HAMD | 14.60 units on a scale | Standard Deviation 5.45 |
| Arm 2 OL Paroxetine + DB Placebo | Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores | Endpoint HAMD | 12.29 units on a scale | Standard Deviation 6.35 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores | Baseline HAMD | 13.84 units on a scale | Standard Deviation 6.05 |
| Arm 3: OL Paroxetine + DB Quetiapine | Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores | Endpoint HAMD | 9.29 units on a scale | Standard Deviation 4.56 |