Augmentation in Tx-resistant OCD: an Open Label Trial

Obsessive Compulsive Disorder Clinical Trial

Official title:

Augment in Treatment-resistent Obsessive-compulsive Disorder: an Open-label Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590642
• Other study ID #: CMP-MD-14
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2007
• Last updated: November 27, 2009
• Start date: April 2006
• Est. completion date: October 2009

Study information

• Verified date: November 2009
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Locations

Country	Name	City	State
United States	Creighton University Department of Psychiatry	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Forest Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View Citation

Chakrabarty K, Bhattacharyya S, Christopher R, Khanna S. Glutamatergic dysfunction in OCD. Neuropsychopharmacology. 2005 Sep;30(9):1735-40. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. — View Citation

Littleton J, Zieglgänsberger W. Pharmacological mechanisms of naltrexone and acamprosate in the prevention of relapse in alcohol dependence. Am J Addict. 2003;12 Suppl 1:S3-11. Review. — View Citation

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. — View Citation

Poyurovsky M, Weizman R, Weizman A, Koran L. Memantine for treatment-resistant OCD. Am J Psychiatry. 2005 Nov;162(11):2191-2. — View Citation

Putzke J, Spanagel R, Tölle TR, Zieglgänsberger 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. — View Citation

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. — View Citation

Saxena S, Rauch SL. Functional neuroimaging and the neuroanatomy of obsessive-compulsive disorder. Psychiatr Clin North Am. 2000 Sep;23(3):563-86. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acamprosate would be efficacious for SSRI resistant OCD symptoms		Patients will be administered 12 weeks of Acamprosate.	Yes
Secondary	Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD.		Patients will be administered 12 weeks of Acamprosate	No