Outcome Assessment and Clinical Improvement in Panic Disorder: Evidence From a Randomized Controlled Trial of Fluoxetine and Placebo

Medical University of South Carolina, Charleston, USA.
American Journal of Psychiatry (Impact Factor: 12.3). 12/1998; 155(11):1570-7. DOI: 10.1176/ajp.155.11.1570
Source: PubMed

ABSTRACT Although panic attacks account for only a portion of the morbidity of panic disorder and panic attack frequency assessments are unreliable, studies of drug efficacy in panic disorder have generally used reduction in panic attack frequency as the primary measure of improvement. The authors studied the efficacy of fluoxetine treatment in panic disorder and measured the relative contributions of changes in symptoms to overall improvement.
Patients with a diagnosis of panic disorder (N = 243) were randomly assigned to treatment with 10 or 20 mg/day of fluoxetine or placebo. Primary outcome measures were change in panic attack frequency and clinician-rated Clinical Global Impression improvement scores. Other assessments included a panic attack inventory, clinician-rated and patient-rated versions of the Panic and Phobic Disorder Change Scale, a phobia rating scale, the Hamilton Anxiety Rating Scale, the 21-item Hamilton Depression Rating Scale, and the Sheehan Disability Scale. Correlations were determined between outcomes in individual symptom domains and overall clinical outcome.
Fluoxetine, particularly the 20-mg/day dose, was associated with more improvement than was placebo in patients with panic disorder across multiple symptom measures, including global improvement, total panic attack frequency, phobic symptoms, and functional impairment. Global improvement was most highly correlated with reductions in overall anxiety and phobic symptoms and least correlated with reduction in panic attacks. Fluoxetine treatment for panic disorder was well tolerated, with a safety profile consistent with that observed for fluoxetine in other disorders.
These data provide support for the efficacy and safety of fluoxetine treatment in reducing panic attacks, phobic symptoms, anxiety, and depressive symptoms in patients with panic disorder. Reductions in panic attack frequency in subjects given either fluoxetine or placebo were less closely related to overall clinical improvement than reductions in phobic avoidance, anxiety, depressive symptoms, and functional impairment, suggesting that outcome measures in this disorder should be more broadly based.

4 Reads
  • Source
    • "Furthermore, Telch et al. (1995) found that changes in anxiety and avoidance predicted functioning at both post-treatment and six-month follow-up. However, other studies found no correlation between symptom reduction and QOL, both in panic disorder and obsessivecompulsive disorder (Michelson et al., 1998; Tenney et al., 2003). "
    [Show abstract] [Hide abstract]
    ABSTRACT: Background This study aimed to explain how quality of life changes during psychotherapy, using a cognitive-behavioural theoretical framework, and examined whether changes in symptoms or changes in cognitions were more influential with regard to quality of life change. Three different hypotheses were tested that might explain the mechanisms by which quality of life changes during group cognitive-behaviour therapy (CBT) for anxiety and depression. Methods 127 outpatients with anxiety and/or depression enrolled in a four-week group CBT programme participated. Measures of anxiety and depression symptoms, cognitive change, and quality of life were administered at baseline and post-treatment. Baseline to post-treatment change scores were calculated and entered into multiple regression analyses. Results Reductions in anxiety and depression symptoms were related to increases in quality of life, whereas cognitive changes were not consistently related to changes in quality of life. Limitations The main limitation was that the study׳s design was not able to assess whether changes in cognitions or symptoms preceded changes in quality of life, as all variables were measured at the same two points in time. Conclusions These results provided evidence that quality of life changes as a result of or, simultaneously with, symptom change. It appears that group CBT does not improve quality of life through strategies designed to change patients׳ cognitions.
    Journal of Affective Disorders 10/2014; 168:72–77. DOI:10.1016/j.jad.2014.06.040 · 3.38 Impact Factor
  • Source
    • "Antidepressants acting on the serotonergic system are effective in treating panic disorder. These include the SSRIs (citalopram, fluvoxamine, fluoxetine, paroxetine, sertraline) (Bakker et al. 2002 ; Hoehn-Saric et al. 1993 ; Lecrubier et al. 1997 ; Michelson et al. 1998 ; Pollack et al. 1998 ; Stahl et al. 2003 ; Wade et al. 1997), the TCAs imipramine and clomipramine (CNCPS, 1992 ; Papp et al. 1997), the SNRI venlafaxine (Bradwejn et al. 2005 ; Liebowitz et al. 2009 ; Pollack et al. 2007a, b), and the irreversible MAOI phenelzine (Sheehan et al. 1980 ; Tyrer et al. 1973). "
    [Show abstract] [Hide abstract]
    ABSTRACT: The evidence-based pharmacotherapy of panic disorder continues to evolve. This paper reviews data on first-line pharmacotherapy, evidence for maintenance treatment, and management options for treatment-refractory patients. A Medline search of research on pharmacotherapy was undertaken, and a previous systematic review on the evidence-based pharmacotherapy of panic disorder was updated. Selective serotonin reuptake inhibitors remain a first-line pharmacotherapy of panic disorder, with the serotonin noradrenaline reuptake inhibitor venlafaxine also an acceptable early option. Temporary co-administration of benzodiazepines can be considered. Maintenance treatment reduces relapse rates, but further research to determine optimal duration is needed. For patients not responding to first-line agents several pharmacotherapy options are available, but there is a notable paucity of data on the optimal choice.
    The International Journal of Neuropsychopharmacology 06/2011; 15(3):1-13. DOI:10.1017/S1461145711000800 · 4.01 Impact Factor
  • Source
    • "First, the LCI only assessed the course of panic attacks, but the course of other aspects such as agoraphobia, anticipatory anxiety and level of functioning were not considered as these aspects were not assessed in the LCI. Including multiple outcome criteria is advised in PD research (Roy-Byrne & Cowley, 1994/1995 ; Shear & Maser, 1994 ; van Balkom et al. 2000) because, for example, overall improvement may be more closely related to other aspects than to panic attacks (Michelson et al. 1998). Second, because of the study design, subjects with the most chronic panic (i.e. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Panic disorder (PD) is generally considered to be a chronic or intermittent disorder. This view may be biased because of a lack of general population studies investigating panic from the onset of an episode onwards. Data regarding the course of subthreshold panic disorder (sub-PD) and predictors of its course are lacking. Using data from a large community-based survey, the Netherlands Mental Health and Incidence Study (NEMESIS), that retrospectively assessed the 2-year course of panic with a Life Chart Interview (LCI), this study investigated remission, chronicity and recurrence in subjects with new episodes of PD or sub-PD. Predictor variables of remission consisted of sociodemographics, psychobiological, environmental, psychiatric and panic-related factors. In PD, remission of panic attacks occurred in 64.5% of subjects, mean time to remission was 5.7 months, and the remission rate was 5.8/100 person-months. In 43.3% of subjects panic was still present after 1 year. Recurrence of panic attacks occurred in 21.4% of those with PD who had achieved remission and for whom sufficient follow-up time was available. In general, the course of sub-PD was more favourable. Predictors of remission were female gender, the absence of ongoing difficulties, subthreshold panic and a low initial frequency of attacks. These results suggest that the course of panic is diverse in the general population, thereby underlining the need for accurate predictors. This requires further research including biological data and additional psychological data. In addition, given the large proportion with a relapse, relapse prevention should be part of any treatment programme.
    Psychological Medicine 05/2009; 40(1):147-57. DOI:10.1017/S0033291709005625 · 5.94 Impact Factor
Show more


4 Reads
Available from