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

NCT02476136 | Unknown

• 1 other identifier: CSDR-1173
• Study Type: observational
• Target: 8,800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety Disorders; Panic Disorder; Obsessive-compulsive Disorder; Post-traumatic Stress Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder

Keywords

individual patient data meta-analysis; anxiety disorder; antidepressants; selective serotonin reuptake inhibitors; serotonin-norepinephrine reuptake inhibitors

Outcome Measures

Primary Outcomes (5)

• Change from baseline on the Hamilton Anxiety Rating Scale (HAM-A)

  Baseline to trial endpoint (8 to 10 weeks)

• Change from baseline on the Liebowitz Social Anxiety Scale (LSAS)

  Baseline to trial endpoint (12 weeks)

• Change from baseline on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

  Baseline to trial endpoint (12 to 13 weeks)

• Change from baseline on the Clinician-Administered PTSD Scale (CAPS)

  Baseline to trial endpoint (12 weeks)

• The total number of panic attacks

  Baseline to trial endpoint (10 to 12 weeks)

Study Arms (2)

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

Interventions

paroxetine, duloxetine, fluoxetine or venlafaxine DRUG

Also known as: Paxil, Cymbalta, Prozac, Effexor

Intervention group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed with an anxiety disorder (GAD, SAD, OCD, PTSD or PD)

You may not qualify if:

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

Sponsors & Collaborators

• prof. Peter de Jonge: lead

Related Publications (1)

• de Vries YA, Roest AM, Burgerhof JGM, de Jonge P. Initial severity and antidepressant efficacy for anxiety disorders, obsessive-compulsive disorder, and posttraumatic stress disorder: An individual patient data meta-analysis. Depress Anxiety. 2018 Jun;35(6):515-522. doi: 10.1002/da.22737. Epub 2018 Apr 16.

  PMID: 29659102 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Panic Disorder; Obsessive-Compulsive Disorder; Stress Disorders, Post-Traumatic; Generalized Anxiety Disorder; Phobia, Social

Interventions

Paroxetine; Duloxetine Hydrochloride; Fluoxetine; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Organic Chemicals; Propylamines; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatric Epidemiology

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 19, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share