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Initial Severity and Antidepressant Efficacy for Anxiety Disorders: an Individual Patient Data Meta-analysis

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ClinicalTrials.gov Identifier: NCT02476136
Recruitment Status : Unknown
Verified September 2016 by prof. Peter de Jonge, University Medical Center Groningen.
Recruitment status was:  Active, not recruiting
First Posted : June 19, 2015
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
prof. Peter de Jonge, University Medical Center Groningen

Brief Summary:
Anxiety disorders are common disorders, which pose a major burden to society and the individual. An anxiety disorder may be treated with medication, in particular with antidepressants such as the selective serotonin reuptake inhibitors (SSRIs). However, much of what is known about antidepressants is derived from research in depression rather than anxiety. In recent years, researchers have found that antidepressants are more effective for severely depressed patients than they are for patients with milder symptoms. It is possible that a similar relationship between symptom severity and antidepressant efficacy exists for anxiety disorders, but there is currently little evidence available to answer this question. As antidepressants are frequently prescribed to patients with mild or moderate anxiety, a clear understanding of their effectiveness across the severity range is vital to inform treatment decisions. Therefore, the purpose of this meta-analysis is to examine whether initial symptom severity affects antidepressant efficacy for anxiety disorders.

Condition or disease Intervention/treatment
Anxiety Disorders Panic Disorder Obsessive-compulsive Disorder Post-traumatic Stress Disorder Generalized Anxiety Disorder Social Anxiety Disorder Drug: paroxetine, duloxetine, fluoxetine or venlafaxine

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 8800 participants
Official Title: Initial Severity and Antidepressant Efficacy for Anxiety Disorders: an Individual Patient Data Meta-analysis
Study Start Date : May 2015
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : December 2016


Group/Cohort Intervention/treatment
Placebo group
Patients participating in one of the included randomized controlled trials, assigned to the placebo group
Intervention group
Patients participating in one of the included randomized controlled trials, assigned to the investigational antidepressant (paroxetine, duloxetine or fluoxetine) or active comparator (venlafaxine) group.
Drug: paroxetine, duloxetine, fluoxetine or venlafaxine
Other Names:
  • Paxil
  • Cymbalta
  • Prozac
  • Effexor




Primary Outcome Measures :
  1. Change from baseline on the Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Baseline to trial endpoint (8 to 10 weeks) ]
  2. Change from baseline on the Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Baseline to trial endpoint (12 weeks) ]
  3. Change from baseline on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: Baseline to trial endpoint (12 to 13 weeks) ]
  4. Change from baseline on the Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Baseline to trial endpoint (12 weeks) ]
  5. The total number of panic attacks [ Time Frame: Baseline to trial endpoint (10 to 12 weeks) ]


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of adults aged 18 and older (with the exception of OCD trials, which may include adolescents aged 14 and older) who have been diagnosed with generalized anxiety disorder (GAD), social anxiety disorder (SAD), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), or panic disorder (PD) and who were randomized to placebo or to treatment with a second-generation antidepressant.
Criteria

Inclusion Criteria:

  • Inclusion in the intent-to-treat population of a randomized controlled trial of a second-generation antidepressant for the short-term treatment of an anxiety disorder
  • Diagnosed with an anxiety disorder (GAD, SAD, OCD, PTSD or PD)

Exclusion Criteria:

  • Assignment to an active comparator that is not a second-generation antidepressant (e.g. a benzodiazepine)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: prof. Peter de Jonge, Professor of Psychiatric Epidemiology, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02476136     History of Changes
Other Study ID Numbers: CSDR-1173
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by prof. Peter de Jonge, University Medical Center Groningen:
individual patient data meta-analysis
anxiety disorder
antidepressants
selective serotonin reuptake inhibitors
serotonin-norepinephrine reuptake inhibitors

Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Panic Disorder
Phobia, Social
Pathologic Processes
Mental Disorders
Trauma and Stressor Related Disorders
Personality Disorders
Phobic Disorders
Antidepressive Agents
Duloxetine Hydrochloride
Fluoxetine
Paroxetine
Venlafaxine Hydrochloride
Serotonin
Serotonin Uptake Inhibitors
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents