Obsessive Compulsive DisorderNCT00590642
Augmentation in Tx-resistant OCD: an Open Label Trial
An observational study of Obsessive Compulsive Disorder, run by Creighton University at 1 site in United States.
Trial summary
This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large percentage of patients fail to respond to medications and have residual symptoms. Such patients are referred to as having treatment resistant OCD. Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Psychiatry clinic
Who may be able to join
- Men and women between 19-55 years of age
- have dx of OCD as determined by the structured clinical interview for DSM-IV axis 1 disorders
- SSRI resistant patients with OCD
- Subjects who are able to comprehend and satisfactorily comply with protocol requirements and have ability to read and write English.
- Signed written informed consent prior to entering any study procedures.
- Concomitant psychotropic medications permitted only if prescribed at stable dose for at least 1 month before screening visit
Who cannot join
- Patients with concurrent DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders
- Patients with concurrent DSM-IV diagnosis of mental retardation
- Patients with concurrent DSM-IV diagnosis of lifetime schizophrenia and other psychotic disorders
- Patients with concurrent DSM-IV diagnosis of lifetime bipolar disorder
- Substance dependence or abuse (excluding nicotine) within 6 months prior to screening visit
- Patients with score of less than 16 on Y-BCOS during screening.
Show all 12Show fewer
- Patients with history of intolerance or hypersensitivity to acamprosate.
- Patients based on history or mental status exam have significant risk fo committing suicide.
- Patients who are homicidal or violent.
- Patients with severe renal impairment
- Female patients who are pregnant or lactating
- Subjects with history of psychosurgery for OCD
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Department of Psychiatry
Omaha, Nebraska, 68131
About this study
Official title: Augment in Treatment-resistent Obsessive-compulsive Disorder: an Open-label Trial
This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large percentage of patients fail to respond to medications and have residual symptoms. Such patients are referred to as having treatment resistant OCD.
Read the detailed description
A patient will receive study drug for about 12 weeks. Throughout the study, the study doctor, on best medical judgment, may gradually increase or decrease the dose of the study medication. The adjustments will dependent on the subject's response and whether the subject has side effects. Once the subject has completed treatment under this study, the subject may resume standard treatment for his/her obsessive compulsive disorder by their regular doctor.
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- obsessive compulsive disorder, OCD, treatment-resistant, SSRI
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acamprosate would be efficacious for SSRI resistant OCD symptoms
Measured: Patients will be administered 12 weeks of Acamprosate.
Secondary outcomes (1)
Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD.
Measured: Patients will be administered 12 weeks of Acamprosate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startApr 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Investigators
- Sriram Ramaswamy, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590642
- Sponsor's protocol ID
- CMP-MD-14
- Status last verified
- Nov 2009
- First submitted
- 11 Dec 2007
- Last updated
- 1 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Hollander E, Greenwald S, Neville D, Johnson J, Hornig CD, Weissman MM. Uncomplicated and comorbid obsessive-compulsive disorder in an epidemiologic sample. Depress Anxiety. 1996-1997;4(3):111-9. doi: 10.1002/(SICI)1520-6394(1996)4:33.0.CO;2-J.
PubMed 9166639Karno M, Golding JM, Sorenson SB, Burnam MA. The epidemiology of obsessive-compulsive disorder in five US communities. Arch Gen Psychiatry. 1988 Dec;45(12):1094-9. doi: 10.1001/archpsyc.1988.01800360042006.
PubMed 3264144den Boer JA. Psychopharmacology of comorbid obsessive-compulsive disorder and depression. J Clin Psychiatry. 1997;58 Suppl 8:17-9.
PubMed 9236731Hollander E. Obsessive-compulsive disorder-related disorders: the role of selective serotonergic reuptake inhibitors. Int Clin Psychopharmacol. 1996 Dec;11 Suppl 5:75-87.
PubMed 9032004Keuneman RJ, Pokos V, Weerasundera R, Castle DJ. Antipsychotic treatment in obsessive-compulsive disorder: a literature review. Aust N Z J Psychiatry. 2005 May;39(5):336-43. doi: 10.1080/j.1440-1614.2005.01591.x.
PubMed 15860020Saxena S, Rauch SL. Functional neuroimaging and the neuroanatomy of obsessive-compulsive disorder. Psychiatr Clin North Am. 2000 Sep;23(3):563-86. doi: 10.1016/s0193-953x(05)70181-7.
PubMed 10986728Moore GJ, MacMaster FP, Stewart C, Rosenberg DR. Case study: caudate glutamatergic changes with paroxetine therapy for pediatric obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 1998 Jun;37(6):663-7. doi: 10.1097/00004583-199806000-00017.
PubMed 9628087Rosenberg DR, MacMaster FP, Keshavan MS, Fitzgerald KD, Stewart CM, Moore GJ. Decrease in caudate glutamatergic concentrations in pediatric obsessive-compulsive disorder patients taking paroxetine. J Am Acad Child Adolesc Psychiatry. 2000 Sep;39(9):1096-103. doi: 10.1097/00004583-200009000-00008.
PubMed 10986805Chakrabarty K, Bhattacharyya S, Christopher R, Khanna S. Glutamatergic dysfunction in OCD. Neuropsychopharmacology. 2005 Sep;30(9):1735-40. doi: 10.1038/sj.npp.1300733.
PubMed 15841109Coric V, Taskiran S, Pittenger C, Wasylink S, Mathalon DH, Valentine G, Saksa J, Wu YT, Gueorguieva R, Sanacora G, Malison RT, Krystal JH. Riluzole augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. Biol Psychiatry. 2005 Sep 1;58(5):424-8. doi: 10.1016/j.biopsych.2005.04.043.
PubMed 15993857Poyurovsky M, Weizman R, Weizman A, Koran L. Memantine for treatment-resistant OCD. Am J Psychiatry. 2005 Nov;162(11):2191-2. doi: 10.1176/appi.ajp.162.11.2191-a. No abstract available.
PubMed 16263867De Witte P, Littleton J, Parot P, Koob G. Neuroprotective and abstinence-promoting effects of acamprosate: elucidating the mechanism of action. CNS Drugs. 2005;19(6):517-37. doi: 10.2165/00023210-200519060-00004.
PubMed 15963001Littleton J, Zieglgansberger W. Pharmacological mechanisms of naltrexone and acamprosate in the prevention of relapse in alcohol dependence. Am J Addict. 2003;12(s1):s3-s11. doi: 10.1111/j.1521-0391.2003.tb00492.x.
PubMed 14972776Dahchour A, De Witte P. Effects of acamprosate on excitatory amino acids during multiple ethanol withdrawal periods. Alcohol Clin Exp Res. 2003 Mar;27(3):465-70. doi: 10.1097/01.ALC.0000056617.68874.18.
PubMed 12658112Putzke J, Spanagel R, Tolle TR, Zieglgansberger W. The anti-craving drug acamprosate reduces c-fos expression in rats undergoing ethanol withdrawal. Eur J Pharmacol. 1996 Dec 12;317(1):39-48. doi: 10.1016/s0014-2999(96)00696-6.
PubMed 8982717
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augment in Treatment-resistent Obsessive-compulsive Disorder: an Open-label Trial
- ClinicalTrials.gov ID
- NCT00590642
- Acronym / sponsor ID
- CMP-MD-14
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- obsessive compulsive disorder, OCD, treatment-resistant, SSRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Apr 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large percentage of patients fail to respond to medications and have residual symptoms. Such patients are referred to as having treatment resistant OCD.
Detailed description
A patient will receive study drug for about 12 weeks. Throughout the study, the study doctor, on best medical judgment, may gradually increase or decrease the dose of the study medication. The adjustments will dependent on the subject's response and whether the subject has side effects. Once the subject has completed treatment under this study, the subject may resume standard treatment for his/her obsessive compulsive disorder by their regular doctor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Psychiatry clinic
Key inclusion criteria (6 listed)
- Men and women between 19-55 years of age
- have dx of OCD as determined by the structured clinical interview for DSM-IV axis 1 disorders
- SSRI resistant patients with OCD
- Subjects who are able to comprehend and satisfactorily comply with protocol requirements and have ability to read and write English.
- Signed written informed consent prior to entering any study procedures.
Key exclusion criteria (12 listed)
- Patients with concurrent DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders
- Patients with concurrent DSM-IV diagnosis of mental retardation
- Patients with concurrent DSM-IV diagnosis of lifetime schizophrenia and other psychotic disorders
- Patients with concurrent DSM-IV diagnosis of lifetime bipolar disorder
- Substance dependence or abuse (excluding nicotine) within 6 months prior to screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acamprosate would be efficacious for SSRI resistant OCD symptoms
Time frame: Patients will be administered 12 weeks of Acamprosate.
1 secondary outcome
Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD.
Time frame: Patients will be administered 12 weeks of Acamprosate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2009.
- Background: PubMed 9166639Hollander E, Greenwald S, Neville D, Johnson J, Hornig CD, Weissman MM. Uncomplicated and comorbid obsessive-compulsive disorder in an epidemiologic sample. Depress Anxiety. 1996-1997;4(3):111-9. doi: 10.1002/(SICI)1520-6394(1996)4:33.0.CO;2-J.
- Background: PubMed 3264144Karno M, Golding JM, Sorenson SB, Burnam MA. The epidemiology of obsessive-compulsive disorder in five US communities. Arch Gen Psychiatry. 1988 Dec;45(12):1094-9. doi: 10.1001/archpsyc.1988.01800360042006.
- Background: PubMed 9236731den Boer JA. Psychopharmacology of comorbid obsessive-compulsive disorder and depression. J Clin Psychiatry. 1997;58 Suppl 8:17-9.
- Background: PubMed 9032004Hollander E. Obsessive-compulsive disorder-related disorders: the role of selective serotonergic reuptake inhibitors. Int Clin Psychopharmacol. 1996 Dec;11 Suppl 5:75-87.
- Background: PubMed 15860020Keuneman RJ, Pokos V, Weerasundera R, Castle DJ. Antipsychotic treatment in obsessive-compulsive disorder: a literature review. Aust N Z J Psychiatry. 2005 May;39(5):336-43. doi: 10.1080/j.1440-1614.2005.01591.x.
- Background: PubMed 10986728Saxena S, Rauch SL. Functional neuroimaging and the neuroanatomy of obsessive-compulsive disorder. Psychiatr Clin North Am. 2000 Sep;23(3):563-86. doi: 10.1016/s0193-953x(05)70181-7.
- Background: PubMed 9628087Moore GJ, MacMaster FP, Stewart C, Rosenberg DR. Case study: caudate glutamatergic changes with paroxetine therapy for pediatric obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 1998 Jun;37(6):663-7. doi: 10.1097/00004583-199806000-00017.
- Background: PubMed 10986805Rosenberg DR, MacMaster FP, Keshavan MS, Fitzgerald KD, Stewart CM, Moore GJ. Decrease in caudate glutamatergic concentrations in pediatric obsessive-compulsive disorder patients taking paroxetine. J Am Acad Child Adolesc Psychiatry. 2000 Sep;39(9):1096-103. doi: 10.1097/00004583-200009000-00008.
- Background: PubMed 15841109Chakrabarty K, Bhattacharyya S, Christopher R, Khanna S. Glutamatergic dysfunction in OCD. Neuropsychopharmacology. 2005 Sep;30(9):1735-40. doi: 10.1038/sj.npp.1300733.
- Background: PubMed 15993857Coric V, Taskiran S, Pittenger C, Wasylink S, Mathalon DH, Valentine G, Saksa J, Wu YT, Gueorguieva R, Sanacora G, Malison RT, Krystal JH. Riluzole augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. Biol Psychiatry. 2005 Sep 1;58(5):424-8. doi: 10.1016/j.biopsych.2005.04.043.
- Background: PubMed 16263867Poyurovsky M, Weizman R, Weizman A, Koran L. Memantine for treatment-resistant OCD. Am J Psychiatry. 2005 Nov;162(11):2191-2. doi: 10.1176/appi.ajp.162.11.2191-a. No abstract available.
- Background: PubMed 15963001De Witte P, Littleton J, Parot P, Koob G. Neuroprotective and abstinence-promoting effects of acamprosate: elucidating the mechanism of action. CNS Drugs. 2005;19(6):517-37. doi: 10.2165/00023210-200519060-00004.
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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.
Sriram Ramaswamy, MD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive Compulsive Disorder, run by Creighton 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 6 inclusion and 12 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 1 Dec 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acamprosate would be efficacious for SSRI resistant OCD symptoms (time frame: Patients will be administered 12 weeks of Acamprosate.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00590642, which also lists 17 linked publications.
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 1 Dec 2009.