Augmentation in Tx-resistant OCD: an Open Label Trial

NCT ID: NCT00590642

Last Updated: 2009-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-10-31

Brief Summary

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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

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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

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Obsessive Compulsive Disorder

Keywords

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obsessive compulsive disorder OCD treatment-resistant SSRI

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Creighton University

Principal Investigators

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Sriram Ramaswamy, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University Department of Psychiatry

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
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Karno 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.

Reference Type BACKGROUND
PMID: 3264144 (View on PubMed)

den Boer JA. Psychopharmacology of comorbid obsessive-compulsive disorder and depression. J Clin Psychiatry. 1997;58 Suppl 8:17-9.

Reference Type BACKGROUND
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Hollander E. Obsessive-compulsive disorder-related disorders: the role of selective serotonergic reuptake inhibitors. Int Clin Psychopharmacol. 1996 Dec;11 Suppl 5:75-87.

Reference Type BACKGROUND
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Keuneman 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.

Reference Type BACKGROUND
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Saxena 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.

Reference Type BACKGROUND
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Moore 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.

Reference Type BACKGROUND
PMID: 9628087 (View on PubMed)

Rosenberg 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.

Reference Type BACKGROUND
PMID: 10986805 (View on PubMed)

Chakrabarty K, Bhattacharyya S, Christopher R, Khanna S. Glutamatergic dysfunction in OCD. Neuropsychopharmacology. 2005 Sep;30(9):1735-40. doi: 10.1038/sj.npp.1300733.

Reference Type BACKGROUND
PMID: 15841109 (View on PubMed)

Coric 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.

Reference Type BACKGROUND
PMID: 15993857 (View on PubMed)

Poyurovsky 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.

Reference Type BACKGROUND
PMID: 16263867 (View on PubMed)

De 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.

Reference Type BACKGROUND
PMID: 15963001 (View on PubMed)

Littleton 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.

Reference Type BACKGROUND
PMID: 14972776 (View on PubMed)

Dahchour 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.

Reference Type BACKGROUND
PMID: 12658112 (View on PubMed)

Putzke 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.

Reference Type BACKGROUND
PMID: 8982717 (View on PubMed)

al Qatari M, Khan S, Harris B, Littleton J. Acamprosate is neuroprotective against glutamate-induced excitotoxicity when enhanced by ethanol withdrawal in neocortical cultures of fetal rat brain. Alcohol Clin Exp Res. 2001 Sep;25(9):1276-83. doi: 10.1097/00000374-200109000-00006.

Reference Type BACKGROUND
PMID: 11584146 (View on PubMed)

Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.

Reference Type BACKGROUND
PMID: 2684084 (View on PubMed)

Other Identifiers

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CMP-MD-14

Identifier Type: -

Identifier Source: org_study_id