Oxytocin Add on Study for Stable Schizophrenic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00506909
First received: July 23, 2007
Last updated: August 8, 2011
Last verified: September 2010
  Purpose

The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms despite being on adequate treatment with antipsychotic medication.


Condition Intervention
Schizophrenia
Drug: Oxytocin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study of Intranasal Oxytocin Augmentation of Antipsychotic Medication in Schizophrenia Patients

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • total score in the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: performed at each visit (weekly) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression-Severity of Illness [ Time Frame: performed at each visit (weekly) ] [ Designated as safety issue: No ]
  • Calgary Depression Scale for Schizophrenia [ Time Frame: performed at each visit (weekly) ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Global Improvement [ Time Frame: Performed at Visits 2-8 (weekly) ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning [ Time Frame: performed at each visit (weekly) ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Scale [ Time Frame: performed at each visit (weekly) ] [ Designated as safety issue: No ]
  • Peabody Picture Vocabulary Test [ Time Frame: Visit 1 only ] [ Designated as safety issue: No ]
  • Letter Number Sequencing Memory Test [ Time Frame: Visits 1, 4, and 8 (every 4 weeks) ] [ Designated as safety issue: No ]
  • Reading Trust in the Eyes Test (RTET) [ Time Frame: Visits 1, 4, 5 and 8 (every 4 weeks) ] [ Designated as safety issue: No ]
  • California Verbal Learning Test-Second Edition [ Time Frame: Visits 1, 4, and 8 (every 4 weeks) ] [ Designated as safety issue: No ]
  • Profile of Mood States [ Time Frame: Visits 1 and 5 (first visit and 5 weeks later) ] [ Designated as safety issue: No ]
  • Paranoid Thought Scale [ Time Frame: Visits 1-8 (weekly) ] [ Designated as safety issue: No ]
  • Arizona Sexual Experience Scale (ASEX) [ Time Frame: Visits 1-8 (weekly) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Group 1: 20 IU BID for the first week, 40IU BID for the following two weeks, 1 week washout, 3 week placebo trial.
Drug: Oxytocin
20 IU BID or 40 IU BID
Drug: Placebo
20 IU BID or 40 IU BID
Experimental: Group 2
Group 2: 3 week placebo trial, 1 week washout, 20 IU BID for the first week, 40IU BID for the following two weeks.
Drug: Oxytocin
20 IU BID or 40 IU BID
Drug: Placebo
20 IU BID or 40 IU BID

Detailed Description:

Schizophrenia patients treated with even the best currently available antipsychotic drugs continue to experience significant symptoms. There is a strong need for better treatments including treatments that can safely be given as adjunct to current antipsychotics in order to improve overall efficacy of treatment.

Oxytocin is a neurohypophyseal peptide best known for its role as a neurohormone involved in parturition and lactation. In addition to these well established peripheral effects, there is a compelling body of converging evidence indicating that oxytocin plays a critical role in the regulation of a number of diverse centrally-mediated behavioral and cognitive processes that are highly relevant to Schizophrenia, including social attachment and memory , (see Argiolas and Gessa 1990; McCarthy and Aaltemus 1997).Furthermore, several lines of research suggest that oxytocin receptors may be an important target for development of novel treatments for schizophrenia. Oxytocin and its receptors exist in several areas of the brain which have been heavily implicated in the pathophysiology of schizophrenia, such as the nucleus accumbens and the hippocampus, (Van Leeuwan et al 1985). Oxytocin administered peripherally inhibits dopamine transmission in the mesolimbic pathway (Sarnyai 1992) et al, 1990). Antipsychotics have been found to elevate the secretion of oxytocin in rats (Uvnas-Moberg et al 1992a) suggesting that endogenous oxytocin may play a role in the therapeutic effects of antipsychotic drugs.

Each subject will be enrolled for 6 week treatment period after a screening phase Study procedure involves weekly clinic visits as an outpatient. Forty patients will be randomly assigned to either 40 IU oxytocin twice daily or vehicle placebo. After 3 weeks, treatments will be crossed over such that subjects that received oxytocin will receive placebo and vice versa. The study ratio is 1:1. Dose of oxytocin is based upon previous studies in humans showing improvement in schizophrenia related changes in behavior and brain function (Kosfeld et al, 2005; Kirsch 2005; Heinrich M 2003).

The total study duration for each individual subject will be approximately 7 weeks, which includes up to 7-day screening period, a baseline (randomization) visit, three week treatment period, 1 week washout, baseline, and three weeks cross over treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult men or women, 18 years of age or older.
  2. Meet DSM-IV criteria for Schizophrenia.
  3. Women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study.
  4. Must be on a therapeutic dose of an atypical antipsychotic medication (examples but not limited to Clozapine Olanzapine, Risperidone, Ziprasidone, Aripiprazole, Seroquel) with no major dose changes for at least 4 weeks.
  5. A minimum PANSS total score of 55 at screening and baseline and a score of at least 4 (moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening.
  6. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline.
  7. Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
  8. Must be able to use nasal spray.
  9. Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.

Exclusion Criteria:

Subjects will be excluded from the study of they meet any of the following criteria:

  1. Are pregnant or are breastfeeding (negative pregnancy test at screening).
  2. A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse.
  3. Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study.
  4. Are unsuitable in any way to participate in this study, in the opinion of the investigator.
  5. Another current DSM-IV diagnosis other than Schizophrenia.

Permitted:

Subjects on one SSRI, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506909

Contacts
Contact: Nicholas Schaffner 619-543-5978 nschaffner@ucsd.edu
Contact: Patrice Cobb 619-543-6495 pcobb@ucsd.edu

Locations
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Nicholas Schaffner    619-543-5978    nschaffner@ucsd.edu   
Contact: Patrice Cobb    619-543-6495    pcobb@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Stanley Medical Research Institute
Investigators
Principal Investigator: David Feifel, MD, PhD University of California, San Diego
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Feifel, MD, PhD, University Of CA, San Diego
ClinicalTrials.gov Identifier: NCT00506909     History of Changes
Other Study ID Numbers: Oxytocin Schizophrenia
Study First Received: July 23, 2007
Last Updated: August 8, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
oxytocin

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014