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A controlled trial of combined sertraline and prolonged exposure therapy in posttraumatic stress disorder
P3. Anxiety disorders and anxiolytics rates of 8-10% in the community and rates of over 50% in treatment seeking populations. Recent data suggest that selective serotonin reuptake inhibitors (SSRI's) are effective in treating PTSD and may be considered first line therapy. However, not all patients respond to these medications and many patients continue to have significant symptoms while others fail to respond at all. In addition, these medications can be accompanied by unpleasant and occasionally intolerable side effects. Mirtazapine is an antidepressant with dual noradrenergic and serotonergic properties, distinct from the SSRI's, and findings from a recent pilot study suggest that it may be effective in PTSD. With these considerations in mind, we undertook a double-blind placebo-controlled study of mirtazapine in PTSD. Methods: Twenty-nine outpatients with chronic PTSD were randomized 2:1 to receive either mirtazapine (up to 45 mg/day) or placebo for 8 weeks. Primary outcome measures included the Short PTSD Rating Interview (SPRINT) and a clinical global improvement measure. Secondary measures included the Davidson Trauma Scale (DTS), Structured Interview for PTSD (SIP), and the Hospital Anxiety and Depression Scale (HADS). Treatment emergent side effects were also assessed. Results: Twenty-nine subjects were randomized and 26 returned for at least one visit, providing evaluable data. Seventeen subjects received mirtazapine and 9 placebo. Twenty subjects (69%) completed the full 8-week trial. The mean(sd) baseline SPRINT score was 21.7(6.0) in the mirtazapine group vs 25.0(4.2) in the placebo group. Response rates measured by global improvement were 64.7°/0 and 20.0% for mirtazapine and placebo, respectively. Treatment effects were noted in favor of mirtazapine on the SPRINT, SIP, DTS, and HADS anxiety subscale. The mean dose of mirtazapine was 39 mg/day and for placebo, 43 mg/day, and the drug was well tolerated. Discussion: Mirtazapine was safe and more effective than placebo on measures of PTSD and general anxiety symptoms.
References [1] Connor KM, Davidson JRT, Weisler RH, Ahearn E. A pilot study of mirtazapine in post-traumatic stress disorder. Int Clin Psychopharmacol 1999; 13:11t 113.
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conducted a randomized controlled, multicenter study of sertraline alone compared to sertraline augmented by psychotherapy (PE) in outpatients with chronic PTSD. Methods: Adult outpatients meeting DSM-IV criteria for chronic PTSD were recruited at three sites. All subjects received open label treatment with sertraline (up to 200 mg/day) for 10 weeks (acute phase). Subjects demonstrating at least 20% improvement were randomized to receive either continued treatment with sertraline or combined individual PE therapy and sertraline for 5 weeks (randomization phase). Outcome was assessed using standard observed-based and self-rated measures of PTSD. Blinded assessments were performed by an independent rater during the double-blind phase and at 6 months after study completion. Results: Preliminary results on a partial sample show that of 53 subjects entering open label treatment, 45 (85%) demonstrated at least 20% improvement and were randomized, with 42 (93% of randomized sample) completing double-blind treatment. Results will focus on the comparison of the effects of sertraline alone vs combined sertraline and PE on the main outcome measures in 60 subjects who completed the double-blind treatment phase. Discussion: The implications of these findings will be discussed.
References [1] Davidson JR, Rothbaum BO, van der Kolk BA, Sikes CR, Farfel GM. Multicenter, double-blind comparison of sertraline and placebo in the treatment of posttraumatic stress disorder. Arch Gen Psych 2001;58:485M-92. [2] Foa EB, Dancu CV, Hembree EA, Jaycox LH, Meadows EA, Street GR A comparison of exposure therapy, stress inoculation training, and their combination for reducing posttraumatic stress disorder in female assault victims. J Consult Clin Psychol 1999;67:194-200.
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Efficacy and safety of sertraline in obsessive compulsive disorder (OCD); 12 Weeks results of controlled clinical trial versus doxepin
I.-A. Dan. Clinical Hospital AI. Obregia, Bucharest, Romania
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A
controlled trial of combined sertraline and prolonged exposure therapy in posttraumatic stress disorder
K.M. Connor 1 , B. Rothbaum 2, E.B. Foa 3, J.R.T. Davidson 1, S. Cahill 3, C. Clary 4. 1Department of Psychiatry and Behavioral
Sciences, Duke University Medical Center, Box 3812 Durham, NC 27710, U.S.A., 2Department of Psychiat~, Emory University, Atlanta, GA, U.S.A.; 3Department of Psychiatr); University of Pennsylvania, Philadelphia, PA, U.S.A.; 4Pfizer, Inc., New York, NY, U.S.A. Objective: Posttraumatic stress disorder (PTSD) is a chronic and disabling condition, with a lifetime prevalence of 7-8%. Both pharmacologic and cognitive behavioral therapies have individually demonstrated efficacy in treating PTSD, and it is possible that combined treatment may confer benefits not observed with either treatment alone. In clinical practice, these treatments are frequently used in combination; however, this approach has not been systematically studied in a controlled setting. To assess the additive benefits of prolonged exposure therapy (PE) when added to treatment with partial responders to medication, we
Background: Doxepin was considered as classic in the treatment of OCD. Nevertheless, in clinical practice, the treatment of OCD has remained an unsolved issue. The use of SSRI in OCD became one of the best treatments choice, but, most of clinicians don't use it in an appropriate way, or do not use it at all. The clinical safety and efficacy of sertraline were already demonstrated. Doxepin appears not to have the same efficacy and compliance, both leading to a lower clinical efficacy and safety. The aim of this study is to estimate the real clinical efficacy of sertraline versus doxepin, in OCD. Methods: This clinical open study included 51 patients (1865 years), both sexes, with OCD (DSM-IV). We divided the patients into 3 groups: group "A" (15 pts.) treated with sertraline 100 mg/day for 12 weeks; group "B" (17 pts.) with sertraline 150mg/day, 4 weeks, then we decreased the daily dose to 100 mg (8 weeks); and group "C" (19 pts.) with doxepin 200 mg/ day (4 weeks), then 150 mg (8 weeks). We evaluated the intensity of OCD (Y-BOCS); anxiety (HAMA), depression (MADRS), CGI, side effects (baseline, week 1,2,3,4,6,8,10,12), and the relapse of OCD symptoms (follow-up: 6 month). Results: 12 pts. from "A" group (80%) were found to be responders after 8 weeks; 3 non-responders, 6 recurrences (50%).
References [1] Connor KM, Davidson JRT, Weisler RH, Ahearn E. A pilot study of mirtazapine in post-traumatic stress disorder. Int Clin Psychopharmacol 1999; 13:11t 113.
$335
conducted a randomized controlled, multicenter study of sertraline alone compared to sertraline augmented by psychotherapy (PE) in outpatients with chronic PTSD. Methods: Adult outpatients meeting DSM-IV criteria for chronic PTSD were recruited at three sites. All subjects received open label treatment with sertraline (up to 200 mg/day) for 10 weeks (acute phase). Subjects demonstrating at least 20% improvement were randomized to receive either continued treatment with sertraline or combined individual PE therapy and sertraline for 5 weeks (randomization phase). Outcome was assessed using standard observed-based and self-rated measures of PTSD. Blinded assessments were performed by an independent rater during the double-blind phase and at 6 months after study completion. Results: Preliminary results on a partial sample show that of 53 subjects entering open label treatment, 45 (85%) demonstrated at least 20% improvement and were randomized, with 42 (93% of randomized sample) completing double-blind treatment. Results will focus on the comparison of the effects of sertraline alone vs combined sertraline and PE on the main outcome measures in 60 subjects who completed the double-blind treatment phase. Discussion: The implications of these findings will be discussed.
References [1] Davidson JR, Rothbaum BO, van der Kolk BA, Sikes CR, Farfel GM. Multicenter, double-blind comparison of sertraline and placebo in the treatment of posttraumatic stress disorder. Arch Gen Psych 2001;58:485M-92. [2] Foa EB, Dancu CV, Hembree EA, Jaycox LH, Meadows EA, Street GR A comparison of exposure therapy, stress inoculation training, and their combination for reducing posttraumatic stress disorder in female assault victims. J Consult Clin Psychol 1999;67:194-200.
•
Efficacy and safety of sertraline in obsessive compulsive disorder (OCD); 12 Weeks results of controlled clinical trial versus doxepin
I.-A. Dan. Clinical Hospital AI. Obregia, Bucharest, Romania
~
A
controlled trial of combined sertraline and prolonged exposure therapy in posttraumatic stress disorder
K.M. Connor 1 , B. Rothbaum 2, E.B. Foa 3, J.R.T. Davidson 1, S. Cahill 3, C. Clary 4. 1Department of Psychiatry and Behavioral
Sciences, Duke University Medical Center, Box 3812 Durham, NC 27710, U.S.A., 2Department of Psychiat~, Emory University, Atlanta, GA, U.S.A.; 3Department of Psychiatr); University of Pennsylvania, Philadelphia, PA, U.S.A.; 4Pfizer, Inc., New York, NY, U.S.A. Objective: Posttraumatic stress disorder (PTSD) is a chronic and disabling condition, with a lifetime prevalence of 7-8%. Both pharmacologic and cognitive behavioral therapies have individually demonstrated efficacy in treating PTSD, and it is possible that combined treatment may confer benefits not observed with either treatment alone. In clinical practice, these treatments are frequently used in combination; however, this approach has not been systematically studied in a controlled setting. To assess the additive benefits of prolonged exposure therapy (PE) when added to treatment with partial responders to medication, we
Background: Doxepin was considered as classic in the treatment of OCD. Nevertheless, in clinical practice, the treatment of OCD has remained an unsolved issue. The use of SSRI in OCD became one of the best treatments choice, but, most of clinicians don't use it in an appropriate way, or do not use it at all. The clinical safety and efficacy of sertraline were already demonstrated. Doxepin appears not to have the same efficacy and compliance, both leading to a lower clinical efficacy and safety. The aim of this study is to estimate the real clinical efficacy of sertraline versus doxepin, in OCD. Methods: This clinical open study included 51 patients (1865 years), both sexes, with OCD (DSM-IV). We divided the patients into 3 groups: group "A" (15 pts.) treated with sertraline 100 mg/day for 12 weeks; group "B" (17 pts.) with sertraline 150mg/day, 4 weeks, then we decreased the daily dose to 100 mg (8 weeks); and group "C" (19 pts.) with doxepin 200 mg/ day (4 weeks), then 150 mg (8 weeks). We evaluated the intensity of OCD (Y-BOCS); anxiety (HAMA), depression (MADRS), CGI, side effects (baseline, week 1,2,3,4,6,8,10,12), and the relapse of OCD symptoms (follow-up: 6 month). Results: 12 pts. from "A" group (80%) were found to be responders after 8 weeks; 3 non-responders, 6 recurrences (50%).