Phase 4
Completed N=124
Quetiapine Augmentation for Treatment-resistant PTSD
Combat Disorders · Stress Disorders, Post-Traumatic
Source: ClinicalTrials.gov NCT00292370 ↗
Enrolled (actual)
124
Serious AEs
4.0%
Results posted
Jul 2014
Primary outcomePrimary: Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. — 72.15; 68.78; 67.90; 51.52 units on a scale — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. |
72.15; 68.78; 67.90; 51.52 | <0.05 sig |
| SECONDARY Change in CGI-I |
3.56; 3.36; 2.61; 2.22 | — |
| SECONDARY Change in Mean PANSS Total and Subscores From Baseline to Endpoint |
46.63; 47.76; 43.92; 42.24 | — |
| SECONDARY Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores |
14.60; 13.84; 12.29; 9.29 | — |
| SECONDARY Change in Total Mean Davidson Trauma Scale (DTS) |
82.19; 77.25; 84.06; 61.50 | — |
| SECONDARY Change in Mean Q-LES-Q Score From Baseline to Endpoint. |
37.85; 40.44; 38.22; 41.06 | — |
| SECONDARY Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint. |
11.60; 12.69; 8.70; 13.19 | — |
| SECONDARY Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint. |
5.07; 4.44; 4.58; 4.66; 6.67; 5.64 | — |
| SECONDARY Change in Arizona Sexual Experience Scale (ASEX) |
22.00; 17.88; 21.93; 16.94 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00292370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.