Disorders - Generalized Anxiety Disorder
McKinnon,
A., Keers, R., Coleman, J. R. I., Lester, K. J., Roberts, S., Arendt, K., etal.
BACKGROUND: Several delivery formats of cognitive behaviour therapy (CBT) for child anxiety have been
proposed, however, there is little consensus on the optimal delivery format. The primary goal of this study was to investigate the impact of the
child's primary anxiety diagnosis on changes in clinical severity (of the primary problem) during individual CBT, group CBT and guided parent-led
CBT. The secondary goal was to investigate the impact of the child's primary anxiety diagnosis on rates of remission for the three treatment
formats. METHOD(S): A sample of 1,253 children (5-12 years; Mage = 9.3, SD = 1.7) was pooled from CBT trials carried out at 10 sites. Children had a
primary diagnosis of generalised anxiety disorder (GAD), social anxiety disorder (SoAD), specific phobia (SP) or separation anxiety disorder (SAD).
Children and parents completed a semistructured clinical interview to assess the presence and severity of DSM-IV psychiatric disorders at
preintervention, postintervention and follow-up. Linear mixture modelling was used to evaluate the primary research question and logistic modelling
was used to investigate the secondary research question. RESULT(S): In children with primary GAD, SAD or SoAD, there were no significant differences
between delivery formats. However, children with primary SP showed significantly larger reductions in clinical severity following individual CBT
compared to group CBT and guided parent-led CBT. The results were mirrored in the analysis of remission responses with the exception that individual
CBT was no longer superior to group CBT for children with a primary SP. The difference between individual and group was not significant when follow-
up data were examined separately. CONCLUSION(S): Data show there may be greater clinical benefit by allocating children with a primary SP to
individual CBT, although future research on cost-effectiveness is needed to determine whether the additional clinical benefits justify the additional
resources required. Copyright © 2018 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of
Association for Child and Adolescent Mental Health.
Journal of Child Psychology &
Psychiatry, & Allied Disciplines, 59(7) : 763-772
- Year: 2018
- Problem: Anxiety Disorders (any), Generalized Anxiety Disorder, Social phobia (social anxiety disorder), Specific
Phobia
- Type: Controlled clinical trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Service Delivery & Improvement, Psychological Interventions
(any), Cognitive & behavioural therapies (CBT), Other service delivery and improvement
interventions
McKinnon, A., Keers, R., Coleman, J. R. I., Lester, K. J., Roberts, S., Arendt, K., etal.
BACKGROUND: Several delivery formats of cognitive behaviour therapy (CBT) for child anxiety have been
proposed, however, there is little consensus on the optimal delivery format. The primary goal of this study was to investigate the impact of the
child's primary anxiety diagnosis on changes in clinical severity (of the primary problem) during individual CBT, group CBT and guided parent-led
CBT. The secondary goal was to investigate the impact of the child's primary anxiety diagnosis on rates of remission for the three treatment
formats. METHOD(S): A sample of 1,253 children (5-12 years; Mage = 9.3, SD = 1.7) was pooled from CBT trials carried out at 10 sites. Children had a
primary diagnosis of generalised anxiety disorder (GAD), social anxiety disorder (SoAD), specific phobia (SP) or separation anxiety disorder (SAD).
Children and parents completed a semistructured clinical interview to assess the presence and severity of DSM-IV psychiatric disorders at
preintervention, postintervention and follow-up. Linear mixture modelling was used to evaluate the primary research question and logistic modelling
was used to investigate the secondary research question. RESULT(S): In children with primary GAD, SAD or SoAD, there were no significant differences
between delivery formats. However, children with primary SP showed significantly larger reductions in clinical severity following individual CBT
compared to group CBT and guided parent-led CBT. The results were mirrored in the analysis of remission responses with the exception that individual
CBT was no longer superior to group CBT for children with a primary SP. The difference between individual and group was not significant when follow-
up data were examined separately. CONCLUSION(S): Data show there may be greater clinical benefit by allocating children with a primary SP to
individual CBT, although future research on cost-effectiveness is needed to determine whether the additional clinical benefits justify the additional
resources required. Copyright © 2018 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of
Association for Child and Adolescent Mental Health.
Journal of Child Psychology &
Psychiatry, & Allied Disciplines, 59(7) : 763-772
- Year: 2018
- Problem: Anxiety Disorders (any), Generalized Anxiety Disorder, Social phobia (social anxiety disorder), Specific
Phobia
- Type: Controlled clinical trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Service Delivery & Improvement, Psychological Interventions
(any), Cognitive & behavioural therapies (CBT), Other service delivery and improvement
interventions
Skodzik, T., Adelt, M. H., Nossek, V. A., Kuck, S. T., Ehring, T.
Worry is a verbal and
abstract thought activity with only little mental imagery involved. It has been shown that this processing bias leads to hampered emotional
processing of worry topics so that worry is maintained in the long run. However, there is some evidence that mental imagery during worrying has the
opposite effect: It leads to stronger emotional reactions than verbal thoughts and thereby fosters emotional processing of worry topics. In the
present study, we examined whether training mental imagery reduces pathological worry. We compared the effect of a novel training in mental imagery
(TMI; n = 37) on various worry-related outcomes to a control training in verbal thinking (TVT; n = 38) and a waiting-list control group (n = 36) in a
sample of pathologically high worriers. Both trainings showed significant within-group decline regarding e.g. pathological worry activity, worry-
related impairment and anxiety assessed both one and five weeks after the training. Cohen's d on different outcome measures ranged from.39 to 1.17.
However, unexpectedly, there were no significant differences between groups on any worry- or affect-related outcome measures. In, sum our training in
general mental imagery skills turned out to be a promising intervention for the reduction of pathological worry. However, we found a training in
verbal thinking to also have unexpected beneficial effects. The theoretical and clinical implications of these findings and methodological
limitations of our study are discussed. Copyright © 2018 Elsevier Ltd
Behaviour Research and
Therapy, 109 : 56-67
- Year: 2018
- Problem: Generalized Anxiety Disorder
- Type: Randomised controlled trials
-
Stage: At risk (indicated or selected prevention)
-
Treatment and intervention: Service Delivery & Improvement, Psychological Interventions
(any), Other Psychological Interventions, Technology, interventions delivered using technology (e.g. online, SMS)
Villabo, M.A., Narayanan, M., Compton, S.N., Kendall, P.C., Neumer, S.P.
Objective: To compare the effectiveness of individual cognitive-behavioral therapy (ICBT) and group CBT (GCBT)
for referred children with anxiety disorders within community mental health clinics. Method: Children (N = 165; ages 7-13 years) referred to 5
clinics in Norway because of primary separation anxiety disorder (SAD), social anxiety disorder (SOC), or generalized anxiety disorder (GAD) based on
Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.) criteria participated in a randomized clinical trial. Participants were
randomized to ICBT, GCBT, or wait list (WL). WL participants were randomized to 1 of the 2 active treatment conditions following the wait period.
Primary outcome was loss of principal anxiety disorder over 12 weeks and 2-year follow-up. Results: Both ICBT and GCBT were superior to WL on all
outcomes. In the intent-to-treat analysis, 52% in ICBT, 65% in GCBT, and 14% in WL were treatment responders. Planned pairwise comparisons found no
significant differences between ICBT and GCBT. GCBT was superior to ICBT for children diagnosed with SOC. Improvement continued during 2-year
follow-up with no significant between-groups differences. Conclusions: Among anxiety disordered children, both individual and group CBT can be
effectively delivered in community clinics. Response rates were similar to those reported in efficacy trials. Although GCBT was more effective than
ICBT for children with SOC following treatment, both treatments were comparable at 2-year follow-up. Dropout rates were lower in GCBT than in ICBT,
suggesting that GCBT may be better tolerated. Response rates continued to improve over the follow-up period, with low rates of relapse. (PsycINFO
Database Record (c) 2018 APA, all rights reserved) Impact Statement What is the public health significance of this article?-Findings indicate that
both individual and group cognitive-behavioral therapy can be effectively delivered by community mental health practitioners with only a minimal
amount of formal training. Outcomes were similar to those reported in more controlled settings. (PsycINFO Database Record (c) 2018 APA, all rights
reserved)
Journal of Consulting and Clinical Psychology, 86(9) : 751-
764
- Year: 2018
- Problem: Anxiety Disorders (any), Generalized Anxiety Disorder, Social phobia (social anxiety disorder)
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Service Delivery & Improvement, Psychological Interventions
(any), Cognitive & behavioural therapies (CBT), Other service delivery and improvement
interventions
Bolinski, F., Kleiboer, A., Karyotaki, E., Bosmans, J. E., Zarski, A. C., Weisel, K. K., Ebert,
D. D., Jacobi, C., Cuijpers, P., Riper, H.
Background: Depression and anxiety are common and co-morbid disorders that affect a
significant proportion of students. Innovative prevention strategies targeting both conditions are needed to reduce their health burden and costs.
ICare Prevent is such an innovative strategy and contains a transdiagnostic individually tailored Internet-based and mobile-supported intervention.
It addresses common risk factors of depression and anxiety as part of a large EU-funded multi-country project* (ICare). Little is known about the
clinical and cost-effectiveness of this type of intervention compared to care as usual (CAU) for college students. We hypothesize that ICare Prevent
will be more (cost-)effective than CAU in the reduction of symptoms of depression and anxiety. Method(s): A three-arm, parallel, randomized
controlled superiority trial will be conducted comparing a guided and an unguided version of ICare Prevent with a control group receiving CAU. The
trial will be open-label but outcome assessors will be blinded. A total of 252 college students (age>=16 years) with subclinical symptoms of
depression defined as a score>=16 on the Center for Epidemiological Studies Depression Scale (CES-D), and/or anxiety, defined as a score>=5 on the
Generalized Anxiety Disorder scale (GAD-7), will be included. Those meeting diagnostic criteria for a depressive or anxiety disorder will be
excluded. The primary outcome is change in disorder specific symptom severity from baseline to post-intervention. Secondary endpoints include self-
reported depression and anxiety symptoms as well as time to onset of a mood or anxiety disorder until 12-month follow-up. Societal costs and quality
of life will be assessed to estimate the intervention's cost-effectiveness compared to CAU. Discussion(s): Transdiagnostic individually tailored
Internet-based prevention could be a (cost-)effective approach to tackle the disease burden of depression and anxiety among college students.
Copyright © 2018 The Author(s).
Trials, 19 (1) (no
pagination)(118) :
- Year: 2018
- Problem: Generalized Anxiety Disorder
- Type: Randomised controlled trials
-
Stage: At risk (indicated or selected prevention)
-
Treatment and intervention: Service Delivery & Improvement, Psychological Interventions
(any), Cognitive & behavioural therapies (CBT), Technology, interventions delivered using technology (e.g. online, SMS)
Giusti, L., Ussorio, D., Salza, A., Malavolta, M., Aggio, A., Bianchini, V., Casacchia, M., Roncone, R.
Background: People with anxiety disorders tend to
focus on unpleasant and threatening stimuli. Our aims were to evaluate: (1) the presence of paranoid ideation, and the jumping to conclusions (JTC)
bias in young suffering from an anxiety disorder and (2) the effectiveness of a cognitive-behavioural intervention (CBT) to manage anxiety combined
with 2 modules to reduce the JTC bias. Methods: Psychopathology, social functioning, metacognition and the JTC bias were investigated in 60 subjects,
randomly assigned to the experimental CBT group + treatment-as-usual (TAU) (n = 35) or to a wait-list group (n = 25) receiving only TAU. Each group
was divided into 2 subgroups based on the score of the SCL-90 subscale paranoid ideation (high paranoid ideation, HP; low paranoid ideation, LP). The
experimental group received a weekly session of a CBT for a 3-month period. Results: At baseline, 46.7% of our sample showed a HP and 38% showed a
JTC biasAt the end of the intervention, greater effectiveness in improving anxious symptoms, paranoid ideation, interpersonal sensitivity and
interpersonal relationship was reported in the experimental CBT + TAU group, with a statistically significant reduction of the JTC bias, displayed by
14.3% of the experimental group versus the 36% of the TAU group. In the same variables, greater benefits were reported for the HP experimental
subgroup. Conclusions: Our study suggests the gains to integrate an anxiety CBT with modules to reduce the JTC bias in subjects with paranoid
ideation, which may negatively impact the course of the disease. (PsycINFO Database Record (c) 2019 APA, all rights reserved)
Early Intervention in Psychiatry, 12(6) : 1072-
1080
- Year: 2018
- Problem: Generalized Anxiety Disorder, Panic
Disorder, Social phobia (social anxiety disorder)
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Psychological Interventions
(any), Cognitive & behavioural therapies (CBT), Other Psychological Interventions
Kodal, A., Fjermestad, K., Bjelland, I., Gjestad, R., Ost, L. G., Bjaastad, J. F., Haugland, B. S. M., Havik, O. E., Heiervang, E., Wergeland, G. J.
Cognitive behavioral therapy (CBT) has
demonstrated favorable long-term outcomes in youth with anxiety disorders in efficacy trials. However, long-term outcomes of CBT delivered in a
community setting are uncertain. This study examined the long-term outcomes of individual (ICBT) and group CBT (GCBT) in youth with anxiety disorders
treated in community mental health clinics. A total of 139 youth (mean age at assessment 15.5 years, range 11-21 years) with a principal diagnosis of
separation anxiety disorder (SAD), social anxiety disorder (SOP), and/or generalized anxiety disorder (GAD) were evaluated, on average, 3.9 years
post-treatment (range 2.2-5.9 years). Outcomes included loss of all inclusion anxiety diagnoses, loss of the principal anxiety diagnosis and changes
in youth- and parent-rated youth anxiety symptoms. At long-term follow-up, there was loss of all inclusion anxiety diagnoses in 53%, loss of the
principal anxiety diagnosis in 63% of participants as well as significant reductions in all anxiety symptom measures. No statistical significant
differences in outcome were obtained between ICBT and GCBT. Participants with a principal diagnosis of SOP had lower odds for recovery, compared to
those with a principal diagnosis of SAD or GAD. In conclusion, outcomes of CBT for youth anxiety disorders delivered in community mental health
clinics were improved at nearly 4 years post-treatment, and recovery rates at long-term follow-up were similar to efficacy trials. Copyright © 2017
The Authors
Journal of Anxiety
Disorders, 53 : 58-67
- Year: 2018
- Problem: Generalized Anxiety Disorder, Specific
Phobia
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Service Delivery & Improvement, Psychological Interventions
(any), Cognitive & behavioural therapies (CBT), Other service delivery and improvement
interventions
Strawn, J. R., Mills, J. A., Cornwall, G. J., Mossman, S. A., Varney, S. T., Keeshin, B. R., Croarkin, P. E.
Objectives: An increasing number of
abandoned clinical trials have forestalled efforts to advance the evidence base for the treatment of mood and anxiety disorders in children and
adolescents. With this in mind, we sought to present and validate a Bayesian approach for the reanalysis of summary data in abandoned clinical trials
and to review and re-evaluate available pharmacokinetic, tolerability, and efficacy data from two large, randomized controlled trials of buspirone in
pediatric patients with generalized anxiety disorder (GAD). Method(s): Prospective, randomized, parallel-group controlled trials of buspirone in
pediatric patients with GAD as well as associated pharmacokinetic studies were identified and data were extracted. In addition to descriptive
statistics, marginal posterior densities for each variable of interest were determined and a Monte Carlo pseudosample was generated with random draws
obtained from the Student's t-distribution to assess, with inferential statistics, differences in variables of interest. Result(s): Buspirone was
evaluated in one flexibly dosed (N = 227) and one fixed-dose (N = 341) trial in children and adolescents aged 6-17 years with a primary diagnosis of
GAD. With regard to improvement in the sum of the Columbia Schedule for Affective Disorders and Schizophrenia GAD items, buspirone did not separate
from placebo in the fixed-dose trial at low (95% CI: -0.78 to 2.39, p = 0.32) or high dose (95% CI: -0.87 to 1.87, p = 0.47) nor did it separate from
placebo in the flexibly dosed study (95% CI: -0.3 to 1.9, p = 0.15). Drop out as a result of a treatment-emergent adverse event was significantly
greater in buspirone-treated patients compared to placebo (p = 0.011). Side effects were consistent with the known profile of buspirone with
lightheadedness occurring more frequently in buspirone-treated patients (p < 0.001). Conclusion(s): Buspirone is well tolerated in pediatric patients
with GAD, although two randomized controlled trials were underpowered to detect small effect sizes (Cohen's d < 0.15). Finally, Bayesian approaches
may facilitate re-examination of data from abandoned clinical trials. Copyright © 2018, Mary Ann Liebert, Inc.
Journal of Child and Adolescent Psychopharmacology, 28(1) : 2-9
- Year: 2018
- Problem: Generalized Anxiety Disorder
- Type: Systematic reviews
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Anxiolytics including benzodiazepines
Weersing, V. R., Brent, D. A., Rozenman, M. S., Gonzalez, A., Jeffreys, M., Dickerson, J. F., Lynch, F. L., Porta, G., Iyengar, S.
Importance: Anxiety and depression affect 30% of youth but
are markedly undertreated compared with other mental disorders, especially in Hispanic populations.\rObjective: To examine whether a pediatrics-based
behavioral intervention targeting anxiety and depression improves clinical outcome compared with referral to outpatient community mental health
care.\rDesign, Setting, and Participants: This 2-center randomized clinical trial with masked outcome assessment conducted between brief behavioral
therapy (BBT) and assisted referral to care (ARC) studied 185 youths (aged 8.0-16.9 years) from 9 pediatric clinics in San Diego, California, and
Pittsburgh, Pennsylvania, recruited from October 6, 2010, through December 5, 2014. Youths who met DSM-IV criteria for full or probable diagnoses of
separation anxiety disorder, generalized anxiety disorder, social phobia, major depression, dysthymic disorder, and/or minor depression; lived with a
consenting legal guardian for at least 6 months; and spoke English were included in the study. Exclusions included receipt of alternate treatment for
anxiety or depression, presence of a suicidal plan, bipolar disorder, psychosis, posttraumatic stress disorder, substance dependence, current abuse,
intellectual disability, or unstable serious physical illness.\rInterventions: The BBT consisted of 8 to 12 weekly 45-minute sessions of behavioral
therapy delivered in pediatric clinics by master's-level clinicians. The ARC families received personalized referrals to mental health care and
check-in calls to support accessing care from master's-level coordinators.\rMain Outcomes and Measures: The primary outcome was clinically
significant improvement on the Clinical Global Impression-Improvement scale (score <=2). Secondary outcomes included the Pediatric Anxiety Rating
Scale, Children's Depression Rating Scale-Revised, and functioning.\rResults: A total of 185 patients were enrolled in the study (mean [SD] age,
11.3 [2.6] years; 107 [57.8%] female; 144 [77.8%] white; and 38 [20.7%] Hispanic). Youths in the BBT group (n=95), compared with those in the ARC
group (n=90), had significantly higher rates of clinical improvement (56.8% vs 28.2%; chi21=13.09, P<.001; number needed to treat, 4), greater
reductions in symptoms (F2,146=5.72; P=.004; Cohen f=0.28), and better functioning (mean [SD], 68.5 [10.7] vs 61.9 [11.9]; t156=3.64; P<.001; Cohen
d=0.58). Ethnicity moderated outcomes, with Hispanic youth having substantially stronger response to BBT (76.5%) than ARC (7.1%) (chi21=14.90;
P<.001; number needed to treat, 2). Effects were robust across sites.\rConclusions and Relevance: A pediatric-based brief behavioral intervention for
anxiety and depression is associated with benefits superior to those of assisted referral to outpatient mental health care. Effects were especially
strong for Hispanic participants, suggesting that the protocol may be a useful tool in addressing ethnic disparities in care.\rTrial Registration:
clinicaltrials.gov Identifier: NCT01147614.
JAMA Psychiatry, 74(6) : 571-
578
- Year: 2017
- Problem: Anxiety Disorders (any), Generalized Anxiety Disorder, Social phobia (social anxiety disorder), Depressive Disorders
- Type: Randomised controlled trials
-
Stage: At risk (indicated or selected prevention), Disorder established (diagnosed disorder)
-
Treatment and intervention: Psychological Interventions
(any), Cognitive & behavioural therapies (CBT), Other Psychological Interventions
Sass, S. M., Evans, T. C., Xiong, K., Mirghassemi, F., Tran, H.
Attentional bias for threatening stimuli in anxiety is a common finding in the literature. The present study addressed whether
attention training toward pleasant stimuli can reduce anxiety symptoms and induce a processing bias in favor of pleasant information in nonpatients
who were selected to score similarly to individuals with generalized anxiety or panic disorder on a measure of worry or physiological arousal,
respectively. Participants were randomly assigned to attention training to pleasant (ATP) stimuli or to a placebo control (PC) condition. All
participants completed baseline and post-test dot-probe measures of attentional bias while event-related brain potentials were recorded. As expected,
worry symptoms decreased in the ATP and not PC condition. ATP was also associated with early evidence (P100 amplitude) of greater attentional
prioritization of probes replacing neutral stimuli within threat-neutral word pairs from pre-to-post intervention and later RT evidence of
facilitated processing of probes replacing pleasant stimuli within pleasant-threat word pairs at post compared to PC. PC was associated with later
evidence (P300 latency) of less efficient evaluation of probes following pleasant stimuli within pleasant-threat word pairs from pre-to-post and
later RT evidence of facilitated processing of probes following threat stimuli within pleasant-threat word pairs at post compared to ATP. Results
highlight early and later mechanisms of attention processing changes and underscore the potential of pleasant stimuli in optimizing attention-
training interventions for anxiety. (PsycINFO Database Record (c) 2017 APA, all rights reserved)
Biological Psychology, 122 : 80-
92
- Year: 2017
- Problem: Generalized Anxiety Disorder, Panic
Disorder
- Type: Randomised controlled trials
-
Stage: At risk (indicated or selected prevention)
-
Treatment and intervention: Psychological Interventions
(any), Attention/cognitive bias
modification
Oldham-Cooper, R., Loades, M.
Background:
Coping Cat (CC), a generic cognitive-behavioral intervention for anxiety disorders in children and young people, is recommended in the United Kingdom
for social anxiety disorder (SAD), generalized anxiety disorder, separation anxiety (SA), and specific phobias (SP), with disorder-specific
approaches generally favored in treatment of anxiety disorders in adults. Objectives: To compare CC with disorder-specific cognitive-behavioral
therapy (CBT) interventions based on anxiety-related treatment outcomes. Study Selection: Primary research articles describing treatment of children
and young people aged 7-17 for SAD, generalized anxiety disorder, SA, and SP, using CC or disorder-specific CBT. Results: Ten studies implemented CC
and four implemented disorder-specific CBT. One study compared CC with a disorder-specific approach. There was a lack of data to support use of CC in
treatment of SPs. However, CC was equally effective as disorder-specific treatments for SA and SAD. Conclusions: A lack of data exists for disorder-
specific CBT interventions compared to CC. (PsycINFO Database Record (c) 2017 APA, all rights reserved)
Journal
of Child and Adolescent Psychiatric Nursing, 30(1) : 6-17
- Year: 2017
- Problem: Anxiety Disorders (any), Generalized Anxiety Disorder, Social phobia (social anxiety disorder), Specific
Phobia
- Type: Systematic reviews
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Psychological Interventions
(any), Cognitive & behavioural therapies (CBT)
Strawn, J. R., Compton, S. N., Robertson, B., Albano, A.
M., Hamdani, M., Rynn, M. A.
Objective: This is a feasibility study evaluating the safety, tolerability, and
potential anxiolytic efficacy of the alpha2 agonist guanfacine extended-release (GXR) in children and adolescents with generalized anxiety disorder
(GAD), separation anxiety disorder (SAD), or social phobia/social anxiety disorder. Methods: Youth aged 6-17 years with a primary diagnosis of GAD,
SAD, and/or social anxiety disorder were treated with flexibly dosed GXR (1-6 mg daily, n = 62) or placebo (n = 21) for 12 weeks. The primary aim of
this study was to determine the safety and tolerability of GXR in youth with anxiety disorders, which involved the analysis of treatment-emergent
adverse events (TEAEs), the emergence of suicidal ideation and behaviors, vital signs, and electrocardiographic/laboratory parameters. Exploratory
efficacy measures included dimensional anxiety scales (Pediatric Anxiety Rating Scale [PARS] and Screen for Child Anxiety Related Emotional Disorders
[SCARED]), as well as the Clinical Global Impression-Improvement (CGI-I) scale. As this was an exploratory study, no inferential statistical analyses
were performed. Results: GXR was safe and well tolerated. Treatment-related mean +/- standard deviation changes in heart rate (GXR: 1.8 +/- 12 beats
per minute [bpm] decrease; placebo: 0.5 +/- 11 bpm decrease), systolic blood pressure (GXR: 2.3 +/- 11 mm Hg decrease; placebo: 1.7 - 11 mm Hg
decrease), or diastolic blood pressure (GXR: 1.3 +/- 9 mm Hg decrease; placebo: 0.9 -7 mm Hg increase) were similar between treatment groups. TEAEs,
including headache, somnolence/fatigue, abdominal pain, and dizziness, were consistent with the known safety profile of GXR.No differences were
observed between treatment groups for PARS and SCARED scores, although at endpoint, a higher proportion of subjects receiving GXR versus placebo
demonstrated CGI-I scores <=2 (54.2% vs. 31.6%), as rated by the clinician investigator. Conclusions: GXR was well tolerated in pediatric subjects
with GAD, SAD, and/or social anxiety disorder. (PsycINFO Database Record (c) 2017 APA, all rights reserved)
Journal of Child and Adolescent
Psychopharmacology, 27(1) : 29-37
- Year: 2017
- Problem: Anxiety Disorders (any), Generalized Anxiety Disorder, Social phobia (social anxiety disorder)
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Other biological interventions