MedTrace Logo

An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial Responders to SSRI or SNRI Antidepressants

NCT00591565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2014-12-18

Study results available
· View outcomes & findings →

Summary

This study is designed to evaluate anxious patients who are only partially responsive to typical SSRI or SNRI anti-anxiety medication therapy. Patients who are less than 50% anxiety-alleviated on their SSRI medication will be asked to join the study and be placed on Acamprosate as well. This type of add-on therapy is common in outpatient psychiatric care. This is a rater-blinded, patient open-label, non-placebo prospective study, where all subjects will receive Acamprosate for 8 weeks. This study would be the first to date in this treatment-resistant patient population, as the investigators will utilize the a comprehensive set of rating scales in order to best categorize patient responses in regards to anxiety, co-occurring depression, sleep disorders, alcohol use, and social functioning with this drug. This study may be pivotal to the initiation of future double-blind, placebo-controlled studies for this agent

Conditions

Interventions

DRUG

Acamprosate

acamprosate 333mg tab, 3 by mouth 3 times a day

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • Thomas L. Schwartz, MD · State University of New York - Upstate Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00591565 on ClinicalTrials.gov