An interventional study of Oxytocin and Placebo in Schizophrenia, sponsored by David Feifel. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by David Feifel · Not applicable, Interventional, and Treatment
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 21 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →David Feifel is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be excluded from the study of they meet any of the following criteria:
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.
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 · Drug: Placebo
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 · Drug: Placebo
20 IU BID or 40 IU BID
20 IU BID or 40 IU BID
Total Score in the Positive and Negative Syndrome Scale (PANSS)
Time frame: performed at each visit (weekly)
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)
| Milestone | All Participants |
|---|---|
| Started | 0 |
| Completed | 0 |
| Not completed | 0 |
No measurements were reported for this outcome.
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No measurements were reported for this outcome.
No measurements were reported for this outcome.
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Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | — | — | — |
The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
| Age, Categorical | All Participants |
|---|---|
| <=18 years | — |
| Between 18 and 65 years | — |
| >=65 years | — |
| Age, Continuous | All Participants |
|---|
| Sex: Female, Male | All Participants |
|---|---|
| Female | — |
| Male | — |
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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David Feifel