AnxietyNCT00591565
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
A study testing Acamprosate in people with Anxiety, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Acamprosate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent is obtained.
- The patient is English-speaking and 18 through 64 years of age inclusive.
- The patient meets the DSM-IV criteria for anxiety disorder as determined by the MINI and psychiatric evaluation. These include: Post-Traumatic Stress Disorder (PTSD), General Anxiety Disorder (GAD), Social Anxiety, and Panic Disorder.
- The patient is currently taking a monotherapy SSRI for ≥ 6 weeks and on a stable, adequate therapeutic for ≥ 4 weeks and remains anxiety symptomatic
- The patient has a total score of at least 16 on the HAM-A scale
- The patient has a score of at least 7 on the HADS anxiety subscale score at the screening and baseline visits.
Show all 10Show fewer
- The patient has a CGI-S rating of 4 or higher at screening
- The patient is in good health as determined by a medical and psychiatric history, medical examination, and cannot have major medical illness that would jeopardize patient health during the study.
- Women must be of nonchildbearing potential [i.e., postmenopausal, be surgically sterile (hysterectomy or tubal ligation)] or must meet all of the following conditions: using a reliable, medically accepted form of contraception for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Reliable forms of contraception include oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; and adequate barrier methods in conjunction with spermicide (abstinence is considered an acceptable contraceptive regimen). Women must be given a pregnancy test (ßHCG), unless they are at least 2 years postmenopausal or surgically sterile, and the results of the test must be negative.
- The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
Who cannot join
- Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- The patient is on more than one antidepressant or takes a standing sedative anxiolytic
- The patient has a substance misuse disorder (including alcohol, caffeine, but not nicotine)
- The patient is a significant risk of suicide
- The patient has recently started psychotherapy or counseling (within last 6 weeks)
- The patient has other psychiatric Axis-I disorders as a principal diagnosis (except anxiety) within 6 months of screening and baseline visits; any history of OCD, psychotic disorder, bipolar disorder, or eating disorder, mental retardation, or clear personality disorder. Patient may have a co-morbid substance misuse, depressive or anxiety disorder if it has been in remission for at least 6 months prior to screening visit.
Show all 10Show fewer
- The patient has previously participated in any clinical study with acamprosate or treated with acamprosate.
- The patient has used an investigational drug within 1 month before the screening visit or is participating in a concurrent clinical trial.
- The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- The patient is unlikely to comply with the study protocol, be unreliable in providing ratings, or is unsuitable for any reason, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University Psychiatry Dept.
Syracuse, New York, 13210
About this study
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
Read the detailed description
Acamprosate is felt to restore the normal glutamate-GABA balance in the human brain. (Glutamate is a stimulating chemical in the brain, while GABA is an inhibitory chemical in the brain.) This GABA-glutamate balance is felt to play a role in the development of anxiety. Low GABA and high glutamate levels (similar to the state of alcohol withdrawal) are implicated. Symptoms of anxiety may include worry, sweating, nausea, palpitation, tremor, again comparable to that of alcohol withdrawal. Sometimes, GABA-promoting sedative drugs, such as diazepam (Valium) are used to raise GABA activity to ward of anxiety symptoms in the non-alcoholic patient. GABA sedatives are also used to treat alcohol withdrawal to restore balance over the short term. Given the similar glutamate-GABA imbalance in anxiety states and (post)-alcohol withdrawal states, Acamprosate may be a likely candidate to treat anxiety. Acamprosate is now FDA approved to prolong sobriety and decrease alcohol consumption.
The usual initial treatment for anxiety is to use a serotonin neurotransmitter enhancing drug, such as fluoxetine (Prozac). These 'SSRI' drugs, unlike the sedatives noted above, do not have addiction potential and are safer to use. In addition serotonin-norepinephrine facilitating drugs are also used (SNRIs) as alternatives. In the anxiety disorder population, only 30-70% of patient achieve full relief of anxiety symptoms when placed on SSRI monotherapy. The usual second-line choice to promote full anxiety symptom remission is to add a GABA-sedative to the serotonergic SSRI. The authors feel that Acamprosate, given its ability to manipulate the GABA-glutamate balance without major side effects, nor addiction, may be a reasonable add-on or augmentation strategy to better alleviate anxiety in SSRI partial responders.
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
- Anxiety
- Being tested
- Acamprosate
- Keywords
- Anxiety, SSRI, SNRI, Acamprosate
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcamprosateDrug
acamprosate 333mg tab, 3 by mouth 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | acamprosate tablets Receives: Drug: Acamprosate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at 8 Weeks in the HAM-A Scale
this is a validated clinician administered scale that can range from 0-44 (mild to severe illness).
Measured: baseline and 8wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJun 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Thomas L. Schwartz, M.D., State University of New York - Upstate Medical University
- Investigators
- Thomas L. Schwartz, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591565
- Sponsor's protocol ID
- CMP-MD-15
- Status last verified
- Dec 2014
- First submitted
- 26 Dec 2007
- Last updated
- 18 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00591565
- Acronym / sponsor ID
- CMP-MD-15
- Conditions
- Anxiety
- Keywords
- Anxiety, SSRI, SNRI, Acamprosate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Jun 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 18 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Acamprosate is felt to restore the normal glutamate-GABA balance in the human brain. (Glutamate is a stimulating chemical in the brain, while GABA is an inhibitory chemical in the brain.) This GABA-glutamate balance is felt to play a role in the development of anxiety. Low GABA and high glutamate levels (similar to the state of alcohol withdrawal) are implicated. Symptoms of anxiety may include worry, sweating, nausea, palpitation, tremor, again comparable to that of alcohol withdrawal. Sometimes, GABA-promoting sedative drugs, such as diazepam (Valium) are used to raise GABA activity to ward of anxiety symptoms in the non-alcoholic patient. GABA sedatives are also used to treat alcohol withdrawal to restore balance over the short term. Given the similar glutamate-GABA imbalance in anxiety states and (post)-alcohol withdrawal states, Acamprosate may be a likely candidate to treat anxiety. Acamprosate is now FDA approved to prolong sobriety and decrease alcohol consumption.
The usual initial treatment for anxiety is to use a serotonin neurotransmitter enhancing drug, such as fluoxetine (Prozac). These 'SSRI' drugs, unlike the sedatives noted above, do not have addiction potential and are safer to use. In addition serotonin-norepinephrine facilitating drugs are also used (SNRIs) as alternatives. In the anxiety disorder population, only 30-70% of patient achieve full relief of anxiety symptoms when placed on SSRI monotherapy. The usual second-line choice to promote full anxiety symptom remission is to add a GABA-sedative to the serotonergic SSRI. The authors feel that Acamprosate, given its ability to manipulate the GABA-glutamate balance without major side effects, nor addiction, may be a reasonable add-on or augmentation strategy to better alleviate anxiety in SSRI partial responders.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Acamprosateacamprosate tablets |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Written informed consent is obtained.
- The patient is English-speaking and 18 through 64 years of age inclusive.
- The patient meets the DSM-IV criteria for anxiety disorder as determined by the MINI and psychiatric evaluation. These include: Post-Traumatic Stress Disorder (PTSD), General Anxiety Disorder (GAD), Social Anxiety, and Panic Disorder.
- The patient is currently taking a monotherapy SSRI for ≥ 6 weeks and on a stable, adequate therapeutic for ≥ 4 weeks and remains anxiety symptomatic
- The patient has a total score of at least 16 on the HAM-A scale
Key exclusion criteria (10 listed)
- Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- The patient is on more than one antidepressant or takes a standing sedative anxiolytic
- The patient has a substance misuse disorder (including alcohol, caffeine, but not nicotine)
- The patient is a significant risk of suicide
- The patient has recently started psychotherapy or counseling (within last 6 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acamprosateacamprosate 333mg tab, 3 by mouth 3 times a day | Drug | 1 |
Primary outcome
Change From Baseline at 8 Weeks in the HAM-A Scale
Time frame: baseline and 8wk
this is a validated clinician administered scale that can range from 0-44 (mild to severe illness).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Anxiety
Recruiting
Evaluating Operation Calm With Children, Parents, and Clinicians
Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
Active, not recruiting
Improving Emotional Wellbeing of University Students: Anxiety Management
Anxiety
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas L. Schwartz, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acamprosate in people with Anxiety, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline at 8 Weeks in the HAM-A Scale (time frame: baseline and 8wk). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.