SchizophreniaOxytocinNCT00506909
Oxytocin Add on Study for Stable Schizophrenic Patients
A study testing Oxytocin in people with Schizophrenia, run by David Feifel at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women, 18 years of age or older.
- Meet DSM-IV criteria for Schizophrenia.
- 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.
- 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.
- 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.
- Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline.
Show all 9Show fewer
- Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
- Must be able to use nasal spray.
- Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
Who cannot join
- Subjects will be excluded from the study of they meet any of the following criteria:
- Are pregnant or are breastfeeding (negative pregnancy test at screening).
- A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse.
- Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study.
- Are unsuitable in any way to participate in this study, in the opinion of the investigator.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92103
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study of Intranasal Oxytocin Augmentation of Antipsychotic Medication in Schizophrenia Patients
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Oxytocin, Placebo
- Keywords
- oxytocin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
20 IU BID or 40 IU BID
PlaceboDrug
20 IU BID or 40 IU BID
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1: 20 IU BID for the first week, 40IU BID for the following two weeks, 1 week washout, 3 week placebo trial. Receives: Drug: Oxytocin; Drug: Placebo |
| Group 2 | Experimental | Group 2: 3 week placebo trial, 1 week washout, 20 IU BID for the first week, 40IU BID for the following two weeks. Receives: Drug: Oxytocin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score in the Positive and Negative Syndrome Scale (PANSS)
Measured: performed at each visit (weekly)
Secondary outcomes (12)
Clinical Global Impression-Severity of Illness
Measured: performed at each visit (weekly)
Calgary Depression Scale for Schizophrenia
Measured: performed at each visit (weekly)
Clinical Global Impression-Global Improvement
Measured: Performed at Visits 2-8 (weekly)
Global Assessment of Functioning
Measured: performed at each visit (weekly)
Hamilton Anxiety Scale
Measured: performed at each visit (weekly)
Peabody Picture Vocabulary Test
Measured: Visit 1 only
Letter Number Sequencing Memory Test
Measured: Visits 1, 4, and 8 (every 4 weeks)
Reading Trust in the Eyes Test (RTET)
Measured: Visits 1, 4, 5 and 8 (every 4 weeks)
California Verbal Learning Test-Second Edition
Measured: Visits 1, 4, and 8 (every 4 weeks)
Profile of Mood States
Measured: Visits 1 and 5 (first visit and 5 weeks later)
Paranoid Thought Scale
Measured: Visits 1-8 (weekly)
Arizona Sexual Experience Scale (ASEX)
Measured: Visits 1-8 (weekly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startMar 2008
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Break in funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Feifel
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Sponsor-investigator, David Feifel, University of California, San Diego
- Investigators
- David Feifel, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506909
- Sponsor's protocol ID
- Oxytocin Schizophrenia
- Acronym
- Oxytocin
- Status last verified
- Jun 2019
- First submitted
- 23 Jul 2007
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Feifel D, Macdonald K, Cobb P, Minassian A. Adjunctive intranasal oxytocin improves verbal memory in people with schizophrenia. Schizophr Res. 2012 Aug;139(1-3):207-10. doi: 10.1016/j.schres.2012.05.018. Epub 2012 Jun 8.
PubMed 22682705Feifel D, Macdonald K, Nguyen A, Cobb P, Warlan H, Galangue B, Minassian A, Becker O, Cooper J, Perry W, Lefebvre M, Gonzales J, Hadley A. Adjunctive intranasal oxytocin reduces symptoms in schizophrenia patients. Biol Psychiatry. 2010 Oct 1;68(7):678-80. doi: 10.1016/j.biopsych.2010.04.039. Epub 2010 Jul 7.
PubMed 20615494
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study of Intranasal Oxytocin Augmentation of Antipsychotic Medication in Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT00506909
- Acronym / sponsor ID
- Oxytocin / Oxytocin Schizophrenia
- Conditions
- Schizophrenia
- Keywords
- oxytocin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Break in funding
- Enrolment
- 21 participants (actual)
- Lead sponsor
- David FeifelUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Mar 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Oxytocin, Drug: PlaceboGroup 1: 20 IU BID for the first week, 40IU BID for the following two weeks, 1 week washout, 3 week placebo trial. |
| Group 2 | Experimental | Drug: Oxytocin, Drug: PlaceboGroup 2: 3 week placebo trial, 1 week washout, 20 IU BID for the first week, 40IU BID for the following two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult men or women, 18 years of age or older.
- Meet DSM-IV criteria for Schizophrenia.
- 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.
- 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.
- 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.
Key exclusion criteria (8 listed)
- Are pregnant or are breastfeeding (negative pregnancy test at screening).
- A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse.
- Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study.
- Are unsuitable in any way to participate in this study, in the opinion of the investigator.
- Another current DSM-IV diagnosis other than Schizophrenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin20 IU BID or 40 IU BID | Drug | Group 1, Group 2 |
| Placebo20 IU BID or 40 IU BID | Drug | Group 1, Group 2 |
Primary outcome
Total Score in the Positive and Negative Syndrome Scale (PANSS)
Time frame: performed at each visit (weekly)
12 secondary outcomes
Clinical Global Impression-Severity of Illness
Time frame: performed at each visit (weekly)
Calgary Depression Scale for Schizophrenia
Time frame: performed at each visit (weekly)
Clinical Global Impression-Global Improvement
Time frame: Performed at Visits 2-8 (weekly)
Global Assessment of Functioning
Time frame: performed at each visit (weekly)
Hamilton Anxiety Scale
Time frame: performed at each visit (weekly)
Peabody Picture Vocabulary Test
Time frame: Visit 1 only
Letter Number Sequencing Memory Test
Time frame: Visits 1, 4, and 8 (every 4 weeks)
Reading Trust in the Eyes Test (RTET)
Time frame: Visits 1, 4, 5 and 8 (every 4 weeks)
California Verbal Learning Test-Second Edition
Time frame: Visits 1, 4, and 8 (every 4 weeks)
Profile of Mood States
Time frame: Visits 1 and 5 (first visit and 5 weeks later)
Paranoid Thought Scale
Time frame: Visits 1-8 (weekly)
Arizona Sexual Experience Scale (ASEX)
Time frame: Visits 1-8 (weekly)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22682705Feifel D, Macdonald K, Cobb P, Minassian A. Adjunctive intranasal oxytocin improves verbal memory in people with schizophrenia. Schizophr Res. 2012 Aug;139(1-3):207-10. doi: 10.1016/j.schres.2012.05.018. Epub 2012 Jun 8.
- Derived from this study: PubMed 20615494Feifel D, Macdonald K, Nguyen A, Cobb P, Warlan H, Galangue B, Minassian A, Becker O, Cooper J, Perry W, Lefebvre M, Gonzales J, Hadley A. Adjunctive intranasal oxytocin reduces symptoms in schizophrenia patients. Biol Psychiatry. 2010 Oct 1;68(7):678-80. doi: 10.1016/j.biopsych.2010.04.039. Epub 2010 Jul 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Feifel, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Schizophrenia, run by David Feifel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Score in the Positive and Negative Syndrome Scale (PANSS) (time frame: performed at each visit (weekly)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00506909, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.