Augmentation in Tx-resistant OCD: an Open Label Trial

NCT00590642 | Completed

• 1 other identifier: CMP-MD-14
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obsessive Compulsive Disorder

Keywords

obsessive compulsive disorder; OCD; treatment-resistant; SSRI

Outcome Measures

Primary Outcomes (1)

• Acamprosate would be efficacious for SSRI resistant OCD symptoms

  Patients will be administered 12 weeks of Acamprosate.

Secondary Outcomes (1)

• Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD.

  Patients will be administered 12 weeks of Acamprosate

Study Arms (1)

1

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Psychiatry clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Creighton University Department of Psychiatry

Omaha, Nebraska, 68131, United States

Location

Related Publications (17)

• 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.

  PMID: 9166639 BACKGROUND

• 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.

  PMID: 3264144 BACKGROUND

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

  PMID: 9236731 BACKGROUND

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

  PMID: 9032004 BACKGROUND

• 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.

  PMID: 15860020 BACKGROUND

• 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.

  PMID: 10986728 BACKGROUND

• 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.

  PMID: 9628087 BACKGROUND

• 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.

  PMID: 10986805 BACKGROUND

• 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.

  PMID: 15841109 BACKGROUND

• 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.

  PMID: 15993857 BACKGROUND

• 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.

  PMID: 16263867 BACKGROUND

• 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.

  PMID: 15963001 BACKGROUND

• 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.

  PMID: 14972776 BACKGROUND

• 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.

  PMID: 12658112 BACKGROUND

• 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.

  PMID: 8982717 BACKGROUND

• 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.

  PMID: 11584146 BACKGROUND

• 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.

  PMID: 2684084 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Sriram Ramaswamy, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: January 10, 2008
• Study Start: April 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

US (1)