Trial Outcomes & Findings for Quetiapine Augmentation for Treatment-resistant PTSD (NCT NCT00292370)
NCT ID: NCT00292370
Last Updated: 2019-10-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
124 participants
Primary outcome timeframe
From baseline (week 8) to endpoint (week 16 or termination)
Results posted on
2019-10-16
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
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 for 8 weeks in a double-blind fashion.
|
|---|---|---|---|
|
Phase I - Open-Label Paroxetine (OLP)
STARTED
|
124
|
0
|
0
|
|
Phase I - Open-Label Paroxetine (OLP)
COMPLETED
|
78
|
0
|
0
|
|
Phase I - Open-Label Paroxetine (OLP)
NOT COMPLETED
|
46
|
0
|
0
|
|
Phase II: OLP + DB Quetiapine or Placebo
STARTED
|
0
|
25
|
25
|
|
Phase II: OLP + DB Quetiapine or Placebo
COMPLETED
|
0
|
21
|
18
|
|
Phase II: OLP + DB Quetiapine or Placebo
NOT COMPLETED
|
0
|
4
|
7
|
Reasons for withdrawal
| Measure |
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
|
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.
|
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 for 8 weeks in a double-blind fashion.
|
|---|---|---|---|
|
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
|
|
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
|
Baseline Characteristics
Gender for Open - Label (OL) population. Double-Blind participants not randomized in OL Phase.
Baseline characteristics by cohort
| Measure |
Arm 1/Open-Label (OL) Paroxetine
n=124 Participants
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
|
Arm 2/OL Paroxetine & Double-blind Placebo
n=25 Participants
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.
|
Arm 3/OL Paroxetine & Double-blind Quetiapine
n=25 Participants
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.
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age - OL Paroxetine
|
52.32 years
STANDARD_DEVIATION 13.23 • n=124 Participants
|
NA years
STANDARD_DEVIATION NA • n=25 Participants
|
NA years
STANDARD_DEVIATION NA • n=25 Participants
|
52.32 years
STANDARD_DEVIATION 13.23 • n=174 Participants
|
|
Age, Customized
Age - Double Blind
|
NA years
STANDARD_DEVIATION NA • n=124 Participants
|
57.17 years
STANDARD_DEVIATION 8.74 • n=25 Participants
|
54.45 years
STANDARD_DEVIATION 13.69 • n=25 Participants
|
54.76 years
STANDARD_DEVIATION 11.48 • n=174 Participants
|
|
Sex/Gender, Customized
Gender OL Females
|
5 Participants
n=124 Participants • Gender for Open - Label (OL) population. Double-Blind participants not randomized in OL Phase.
|
—
|
—
|
5 Participants
n=124 Participants • Gender for Open - Label (OL) population. Double-Blind participants not randomized in OL Phase.
|
|
Sex/Gender, Customized
Gender OL Males
|
119 Participants
n=124 Participants • Gender for Open - Label (OL) population. Double-Blind participants not randomized in OL Phase.
|
—
|
—
|
119 Participants
n=124 Participants • Gender for Open - Label (OL) population. Double-Blind participants not randomized in OL Phase.
|
|
Sex/Gender, Customized
Females Double Blind
|
0 Participants
Gender for Double-Blind phase II
|
1 Participants
n=25 Participants • Gender for Double-Blind phase II
|
1 Participants
n=25 Participants • Gender for Double-Blind phase II
|
2 Participants
n=50 Participants • Gender for Double-Blind phase II
|
|
Sex/Gender, Customized
Males Double Blind
|
0 Participants
Gender for Double-Blind phase II
|
24 Participants
n=25 Participants • Gender for Double-Blind phase II
|
24 Participants
n=25 Participants • Gender for Double-Blind phase II
|
48 Participants
n=50 Participants • Gender for Double-Blind phase II
|
|
Race/Ethnicity, Customized
OL Amer Indian/ Alask Native
|
2 Participants
n=124 Participants • Race/Ethnicity for Open-Label Phase participants
|
—
|
—
|
2 Participants
n=124 Participants • Race/Ethnicity for Open-Label Phase participants
|
|
Race/Ethnicity, Customized
OL African American
|
50 Participants
n=124 Participants • Race/Ethnicity for Open-Label Phase participants
|
—
|
—
|
50 Participants
n=124 Participants • Race/Ethnicity for Open-Label Phase participants
|
|
Race/Ethnicity, Customized
OL White
|
68 Participants
n=124 Participants • Race/Ethnicity for Open-Label Phase participants
|
—
|
—
|
68 Participants
n=124 Participants • Race/Ethnicity for Open-Label Phase participants
|
|
Race/Ethnicity, Customized
OL Unknown or Not Reported
|
4 Participants
n=124 Participants • Race/Ethnicity for Open-Label Phase participants
|
—
|
—
|
4 Participants
n=124 Participants • Race/Ethnicity for Open-Label Phase participants
|
|
Race/Ethnicity, Customized
DB Amer Indian/ Alaska Native
|
—
|
0 Participants
n=25 Participants • Race/Ethnicity for Double-Blind participants
|
0 Participants
n=25 Participants • Race/Ethnicity for Double-Blind participants
|
0 Participants
n=50 Participants • Race/Ethnicity for Double-Blind participants
|
|
Race/Ethnicity, Customized
DB African American
|
—
|
15 Participants
n=25 Participants • Race/Ethnicity for Double-Blind participants
|
10 Participants
n=25 Participants • Race/Ethnicity for Double-Blind participants
|
25 Participants
n=50 Participants • Race/Ethnicity for Double-Blind participants
|
|
Race/Ethnicity, Customized
DB White
|
—
|
9 Participants
n=25 Participants • Race/Ethnicity for Double-Blind participants
|
14 Participants
n=25 Participants • Race/Ethnicity for Double-Blind participants
|
23 Participants
n=50 Participants • Race/Ethnicity for Double-Blind participants
|
|
Race/Ethnicity, Customized
DB Unknown/ Not Reported
|
—
|
1 Participants
n=25 Participants • Race/Ethnicity for Double-Blind participants
|
1 Participants
n=25 Participants • Race/Ethnicity for Double-Blind participants
|
2 Participants
n=50 Participants • Race/Ethnicity for Double-Blind participants
|
|
Region of Enrollment
United States
|
124 Participants
n=124 Participants • Same region as in OL phase
|
—
|
—
|
124 Participants
n=124 Participants • Same region as in OL phase
|
|
Years of Education
Education - Open Label (OL) Population
|
13.12 years
STANDARD_DEVIATION 2.05 • n=124 Participants
|
NA years
STANDARD_DEVIATION NA • n=25 Participants
|
NA years
STANDARD_DEVIATION NA • n=25 Participants
|
13.12 years
STANDARD_DEVIATION 2.05 • n=174 Participants
|
|
Years of Education
Education - Double Blind (DB), Phase II
|
NA years
STANDARD_DEVIATION NA • n=124 Participants
|
13.22 years
STANDARD_DEVIATION 2.74 • n=25 Participants
|
12.55 years
STANDARD_DEVIATION 1.53 • n=25 Participants
|
12.89 years
STANDARD_DEVIATION 2.24 • n=174 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 2 OL Paroxetine + DB Placebo
n=25 Participants
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 (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine
|
Arm 3: OL Paroxetine + DB Quetiapine
n=25 Participants
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine
|
|---|---|---|
|
Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.
CAPS Total Baseline
|
72.15 units on a scale
Standard Deviation 15.96
|
68.78 units on a scale
Standard Deviation 17.01
|
|
Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.
CAPS Total Endpoint
|
67.90 units on a scale
Standard Deviation 14.90
|
51.52 units on a scale
Standard Deviation 19.68
|
SECONDARY outcome
Timeframe: From Baseline (week 8) to Endpoint (week 16 or termination)Population: Randomized participants with CGI-I score
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.
Outcome measures
| Measure |
Arm 2 OL Paroxetine + DB Placebo
n=25 Participants
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 (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine
|
Arm 3: OL Paroxetine + DB Quetiapine
n=25 Participants
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine
|
|---|---|---|
|
Change in CGI-I
Baseline CGI-I
|
3.56 units on a scale
Standard Deviation .85
|
3.36 units on a scale
Standard Deviation .88
|
|
Change in CGI-I
Endpoint CGI-I
|
2.61 units on a scale
Standard Deviation .79
|
2.22 units on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Baseline (week 8) to Endpoint (week 16 or termination)Population: Randomized participants with a PANSS score
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.
Outcome measures
| Measure |
Arm 2 OL Paroxetine + DB Placebo
n=25 Participants
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 (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine
|
Arm 3: OL Paroxetine + DB Quetiapine
n=25 Participants
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine
|
|---|---|---|
|
Change in Mean PANSS Total and Subscores From Baseline to Endpoint
Baseline Total PANSS
|
46.63 units on a scale
Standard Deviation 10.13
|
47.76 units on a scale
Standard Deviation 11.09
|
|
Change in Mean PANSS Total and Subscores From Baseline to Endpoint
Endpoint Total PANSS
|
43.92 units on a scale
Standard Deviation 6.81
|
42.24 units on a scale
Standard Deviation 8.07
|
SECONDARY outcome
Timeframe: From Baseline (week 8) to Endpoint (week 16 or Termination)Population: Randomized participants with a HAMD score.
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.
Outcome measures
| Measure |
Arm 2 OL Paroxetine + DB Placebo
n=25 Participants
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 (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine
|
Arm 3: OL Paroxetine + DB Quetiapine
n=25 Participants
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine
|
|---|---|---|
|
Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores
Baseline HAMD
|
14.60 units on a scale
Standard Deviation 5.45
|
13.84 units on a scale
Standard Deviation 6.05
|
|
Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores
Endpoint HAMD
|
12.29 units on a scale
Standard Deviation 6.35
|
9.29 units on a scale
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: From Baseline (week 8) to Endpoint (week 16 or Termination)Population: Randomized participants with a DTS score
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).
Outcome measures
| Measure |
Arm 2 OL Paroxetine + DB Placebo
n=25 Participants
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 (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine
|
Arm 3: OL Paroxetine + DB Quetiapine
n=25 Participants
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine
|
|---|---|---|
|
Change in Total Mean Davidson Trauma Scale (DTS)
Baseline DTS
|
82.19 units on a scale
Standard Deviation 24.60
|
77.25 units on a scale
Standard Deviation 25.94
|
|
Change in Total Mean Davidson Trauma Scale (DTS)
Endpoint DTS
|
84.06 units on a scale
Standard Deviation 21.92
|
61.50 units on a scale
Standard Deviation 18.20
|
SECONDARY outcome
Timeframe: From Baseline (week 8) to Endpoint (week 16 or termination)Population: Randomized participants with a Q-LES-Q score.
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.
Outcome measures
| Measure |
Arm 2 OL Paroxetine + DB Placebo
n=25 Participants
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 (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine
|
Arm 3: OL Paroxetine + DB Quetiapine
n=25 Participants
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine
|
|---|---|---|
|
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
|
40.44 units on a scale
Standard Deviation 8.82
|
|
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
|
41.06 units on a scale
Standard Deviation 6.70
|
SECONDARY outcome
Timeframe: From Baseline (week 8) to Endpoint (week 16)Population: Randomized participants with a PSQI score.
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.
Outcome measures
| Measure |
Arm 2 OL Paroxetine + DB Placebo
n=25 Participants
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 (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine
|
Arm 3: OL Paroxetine + DB Quetiapine
n=25 Participants
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine
|
|---|---|---|
|
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
|
12.69 units on a scale
Standard Deviation 3.46
|
|
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
|
13.19 units on a scale
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: Baseline (week 8) to Endpoint (week 16 or termination)Population: Randomized participants with an SDS score
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).
Outcome measures
| Measure |
Arm 2 OL Paroxetine + DB Placebo
n=25 Participants
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 (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine
|
Arm 3: OL Paroxetine + DB Quetiapine
n=25 Participants
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine
|
|---|---|---|
|
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
|
4.44 units on a scale
Standard Deviation 2.95
|
|
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
|
4.66 units on a scale
Standard Deviation 2.34
|
|
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
|
5.64 units on a scale
Standard Deviation 2.93
|
|
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
|
4.95 units on a scale
Standard Deviation 1.83
|
|
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
|
4.72 units on a scale
Standard Deviation 2.48
|
|
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
|
4.61 units on a scale
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: From Baseline (week 8) to Endpoint (week 16 or termination)Population: Randomized participants with an ASEX score.
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.
Outcome measures
| Measure |
Arm 2 OL Paroxetine + DB Placebo
n=25 Participants
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 (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine
|
Arm 3: OL Paroxetine + DB Quetiapine
n=25 Participants
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine
|
|---|---|---|
|
Change in Arizona Sexual Experience Scale (ASEX)
Baseline ASEX
|
22.00 units on a scale
Standard Deviation 6.68
|
17.88 units on a scale
Standard Deviation 5.33
|
|
Change in Arizona Sexual Experience Scale (ASEX)
Endpoint ASEX
|
21.93 units on a scale
Standard Deviation 7.45
|
16.94 units on a scale
Standard Deviation 5.84
|
Adverse Events
Arm 1: Open Label (OL) Paroxetine
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm 2 OL Paroxetine + DB Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 3: OL Paroxetine + DB Quetiapine
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Open Label (OL) Paroxetine
n=124 participants at risk
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 of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.
Open Label (OL) Paroxetine: Open-label Paroxetine
|
Arm 2 OL Paroxetine + DB Placebo
n=25 participants at risk
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 (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine
|
Arm 3: OL Paroxetine + DB Quetiapine
n=25 participants at risk
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine
|
|---|---|---|---|
|
Psychiatric disorders
Hospitalized - Suicide Ideation
|
0.81%
1/124 • Number of events 1 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
0.00%
0/25 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
0.00%
0/25 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
|
Cardiac disorders
Hypotension
|
1.6%
2/124 • Number of events 2 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
0.00%
0/25 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
4.0%
1/25 • Number of events 1 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
|
Cardiac disorders
Hospitalized - scheduled cardiac stint
|
1.6%
2/124 • Number of events 2 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
0.00%
0/25 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
0.00%
0/25 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
0.00%
0/124 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
0.00%
0/25 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
4.0%
1/25 • Number of events 1 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
Other adverse events
| Measure |
Arm 1: Open Label (OL) Paroxetine
n=124 participants at risk
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 of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.
Open Label (OL) Paroxetine: Open-label Paroxetine
|
Arm 2 OL Paroxetine + DB Placebo
n=25 participants at risk
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 (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine
|
Arm 3: OL Paroxetine + DB Quetiapine
n=25 participants at risk
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine
|
|---|---|---|---|
|
Reproductive system and breast disorders
Sexual Side effects
|
8.1%
10/124 • Number of events 10 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
4.0%
1/25 • Number of events 1 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
4.0%
1/25 • Number of events 1 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
|
Nervous system disorders
Sedation
|
5.6%
7/124 • Number of events 7 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
4.0%
1/25 • Number of events 1 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
12.0%
3/25 • Number of events 3 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
|
Nervous system disorders
Dizziness
|
4.8%
6/124 • Number of events 6 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
0.00%
0/25 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
0.00%
0/25 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
|
Cardiac disorders
Heart palpitation
|
0.00%
0/124 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
0.00%
0/25 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
8.0%
2/25 • Number of events 2 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/124 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
0.00%
0/25 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
8.0%
2/25 • Number of events 2 • Collected over 4 months per subject.
Collected by open-ended questions, vitals, standardized report form, and chart review at visits every two weeks, as well as by lab assessments between phases I and II.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place