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Oxytocin Add on Study for Stable Schizophrenic Patients (Oxytocin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00506909
Recruitment Status : Terminated (Break in funding)
First Posted : July 25, 2007
Results First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Stanley Medical Research Institute
Information provided by (Responsible Party):
David Feifel, University of California, San Diego

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: Oxytocin Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study of Intranasal Oxytocin Augmentation of Antipsychotic Medication in Schizophrenia Patients
Study Start Date : March 2008
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Oxytocin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Total Score in the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: performed at each visit (weekly) ]

Secondary Outcome Measures :
  1. Clinical Global Impression-Severity of Illness [ Time Frame: performed at each visit (weekly) ]
  2. Calgary Depression Scale for Schizophrenia [ Time Frame: performed at each visit (weekly) ]
  3. Clinical Global Impression-Global Improvement [ Time Frame: Performed at Visits 2-8 (weekly) ]
  4. Global Assessment of Functioning [ Time Frame: performed at each visit (weekly) ]
  5. Hamilton Anxiety Scale [ Time Frame: performed at each visit (weekly) ]
  6. Peabody Picture Vocabulary Test [ Time Frame: Visit 1 only ]
  7. Letter Number Sequencing Memory Test [ Time Frame: Visits 1, 4, and 8 (every 4 weeks) ]
  8. Reading Trust in the Eyes Test (RTET) [ Time Frame: Visits 1, 4, 5 and 8 (every 4 weeks) ]
  9. California Verbal Learning Test-Second Edition [ Time Frame: Visits 1, 4, and 8 (every 4 weeks) ]
  10. Profile of Mood States [ Time Frame: Visits 1 and 5 (first visit and 5 weeks later) ]
  11. Paranoid Thought Scale [ Time Frame: Visits 1-8 (weekly) ]
  12. Arizona Sexual Experience Scale (ASEX) [ Time Frame: Visits 1-8 (weekly) ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00506909

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United States, California
University of California San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
David Feifel
Stanley Medical Research Institute
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Principal Investigator: David Feifel, MD, PhD University of California, San Diego
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Feifel, Professor, University of California, San Diego Identifier: NCT00506909    
Other Study ID Numbers: Oxytocin Schizophrenia
First Posted: July 25, 2007    Key Record Dates
Results First Posted: September 25, 2019
Last Update Posted: September 25, 2019
Last Verified: June 2019
Keywords provided by David Feifel, University of California, San Diego:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Reproductive Control Agents
Physiological Effects of Drugs