Major Depressive DisorderNCT01211756
Oxytocin Add-on for Stable Depressed Patients
A study testing Oxytocin in people with Major Depressive Disorder and Dysthymia Disorder, 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 depression symptoms in patients with Major Depressive Disorder (MDD) or Dysthymia Disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Dysthymia Disorder
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2015
- 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 Major Depressive Disorder or Dysthymia Disorder
- 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 1 or 2 antidepressants with no major dose changes for at least 4 weeks at randomization.
- MADRS score of >17 at randomization
- Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline.
Show all 12Show 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. (If patient cannot then he/she will be considered for the acute only portion of this study.)
- Permitted:
- Subjects on up to 2 sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study.
- Minor adjustments in sleep medication is acceptable. Patients will be asked to notify the study doctor of any changes to sleep aids.
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 Major Depressive Disorder or Dysthymia Disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study of Intranasal Oxytocin Augmentation of Antidepressant Medication in Depressed Patients.
The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve depression symptoms in patients with Major Depressive Disorder (MDD) or Dysthymia Disorder.
Read the detailed description
Depression patients treated with even the best currently available antidepressant drugs continue to experience significant symptoms. There is a strong need for better treatments including treatments that can safely be given adjunctively with concurrent antidepressants 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 mood regulation and mood disorders, including social attachment (Argiolas and Gessa 1990; McCarthy and Aaltemus 1997).
Each subject will be enrolled for a 8 week treatment period after a screening phase. Study procedure involves weekly clinic visits as an outpatient. Twenty patients will be randomly assigned to either 40 IU oxytocin twice daily or vehicle placebo. After 4 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 psychiatric populations 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 9 weeks, which includes up to 31-day screening period, a baseline (randomization) visit, four week treatment period, 1 week washout, baseline 2 visit, and four weeks cross over treatment.
- Conditions
- Major Depressive Disorder, Dysthymia Disorder
- Being tested
- Oxytocin, Placebo
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
20 IU BID for one week, followed by 40 IU BID for 3 weeks.
PlaceboDrug
20 IU BID for one week, followed by 40 IU BID for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | 20 IU of intranasal oxytocin twice per day for the first week, 40 IU of intranasal oxytocin twice per day for the following 3 weeks, one week wash out, 4 week placebo trial. Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Four week placebo trial, one week wash out, 20 IU of intranasal oxytocin twice per day for one week, 40 IU of intranasal oxytocin twice per day for 3 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score on Montgomery-Asberg Depression Rating Score (MADRS)
The MADRS is a clinician-rated assessment used to measure the severity of depressive episodes in patients with mood disorders. The measure contains 10 items and each item is scored in a range of 0 to 6 points, with higher score indicating increased depressive symptoms.
Measured: Performed at each visit (weekly)
Secondary outcomes (12)
Global Assessment of Functioning (GAF)
The GAF considers psychological, social, and occupational functioning on a hypothetical continuum of mental health illness. Scores on the GAF range from 1 (extremely severe) to 100 (superior functioning).
Measured: Performed at each visit (weekly)
Clinical Global Impression-Severity of Illness (CGI-S)
The CGI-S is used to evaluate changes in overall severity of illness. Scores on the CGI-S range from 1 (not at all) to 7(among the most extremely ill).
Measured: Performed at each visit (weekly)
Clinical Global Impression-Global Improvement (CGI-I)
The CGI-I is a global assessment to evaluate the subjects' improvement or worsening from baseline. Scores on the CGI-I scale range from 1 (very much improved) to 7 (very much worse).
Measured: Performed at each visit (weekly)
Young Mania Rating Scale (YMRS)
The YMRS is an 11-item assessment used to assess the severity of mania in patients with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observed.
Measured: Performed at each visit (weekly)
Hamilton-Anxiety Scale (HAM-A)
The HAM-A is a clinician administered scale for the evaluation of anxiety symptoms. The HAM-A consists of 14 items of which each item is scored 0 (not present) to 4 (very severe).
Measured: Performed at each visit (weekly)
Reading Trust in the Mind's Eye Test
The subject will view approximately 16 faces and asked to rate trustfulness of the person in the picture.
Measured: Performed at the beginning and end of each treatment arm.
Profile of Mood States (POMS)
The POMS is a self-rated scale to assess current mood states. The POMS consists of 65 words that the subject will rate from 1 (not at all) to 5 (extremely) based on how he/she feels at the time.
Measured: Performed at the beginning and end of each treatment arm
Arizona Sexual Experience Scale (ASEX)
The ASEX is a self-rated scale to assess sexual functioning. The ASEX consists of 5 items that the subject will rate from 1 (Extremely strong, easily, or satisfying) to 6 (Absent or never) based on how he/she feels at the time.
Measured: Performed at each visit (weekly)
Peabody Picture Vocabulary Test
The subject is read a series of words and is shown line drawings and is asked to match the word to the drawing.
Measured: Performed at the beginning of the study
California Verbal Learning Test
The subject is read a list of words and asked to repeat them back first after the list is read and again 20 minutes later.
Measured: Performed at the beginning and end of each treatment arm
Letter Number Sequencing Memory Test
The examinee is read a combination of numbers and letters and is asked to recall the numbers first in ascending order and then the letters in alphabetical order. Each item consists of three trials, and each trial is a different combination of numbers and letters.
Measured: Performed at the beginning and end of each treatment arm
Continuous Performance Test (CPT)
Patients are told that they will see a series of letters presented on a screen. They are told to click a computer mouse only when they see the "target" stimulus, for instance the letter "X", and must refrain from clicking if they see any other letter presented.
Measured: Performed at the beginning and end of each treatment arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2015
- Study completionDec 2015
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.
- Other trials for Major Depressive DisorderStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Feifel
- Sponsor type
- University, hospital or other
- 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
- NCT01211756
- Sponsor's protocol ID
- Oxytocin Depression
- Status last verified
- Dec 2016
- First submitted
- 28 Sep 2010
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Antidepressant Medication in Depressed Patients.
- ClinicalTrials.gov ID
- NCT01211756
- Acronym / sponsor ID
- Oxytocin Depression
- Conditions
- Major Depressive Disorder, Dysthymia Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Break in funding
- Enrolment
- 1 participants (actual)
- Lead sponsor
- David FeifelUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Sep 2010 (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 depression symptoms in patients with Major Depressive Disorder (MDD) or Dysthymia Disorder.
Detailed description
Depression patients treated with even the best currently available antidepressant drugs continue to experience significant symptoms. There is a strong need for better treatments including treatments that can safely be given adjunctively with concurrent antidepressants 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 mood regulation and mood disorders, including social attachment (Argiolas and Gessa 1990; McCarthy and Aaltemus 1997).
Each subject will be enrolled for a 8 week treatment period after a screening phase. Study procedure involves weekly clinic visits as an outpatient. Twenty patients will be randomly assigned to either 40 IU oxytocin twice daily or vehicle placebo. After 4 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 psychiatric populations 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 9 weeks, which includes up to 31-day screening period, a baseline (randomization) visit, four week treatment period, 1 week washout, baseline 2 visit, and four 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 |
|---|---|---|
| Oxytocin | Experimental | Drug: Oxytocin20 IU of intranasal oxytocin twice per day for the first week, 40 IU of intranasal oxytocin twice per day for the following 3 weeks, one week wash out, 4 week placebo trial. |
| Placebo | Placebo comparator | Drug: PlaceboFour week placebo trial, one week wash out, 20 IU of intranasal oxytocin twice per day for one week, 40 IU of intranasal oxytocin twice per day for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult men or women, 18 years of age or older.
- Meet DSM-IV criteria for Major Depressive Disorder or Dysthymia Disorder
- 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 1 or 2 antidepressants with no major dose changes for at least 4 weeks at randomization.
- MADRS score of >17 at randomization
Key exclusion criteria (6 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 Major Depressive Disorder or Dysthymia Disorder
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 for one week, followed by 40 IU BID for 3 weeks. | Drug | Oxytocin |
| Placebo20 IU BID for one week, followed by 40 IU BID for 3 weeks. | Drug | Placebo |
Primary outcome
Total Score on Montgomery-Asberg Depression Rating Score (MADRS)
Time frame: Performed at each visit (weekly)
The MADRS is a clinician-rated assessment used to measure the severity of depressive episodes in patients with mood disorders. The measure contains 10 items and each item is scored in a range of 0 to 6 points, with higher score indicating increased depressive symptoms.
12 secondary outcomes
Global Assessment of Functioning (GAF)
Time frame: Performed at each visit (weekly)
Clinical Global Impression-Severity of Illness (CGI-S)
Time frame: Performed at each visit (weekly)
Clinical Global Impression-Global Improvement (CGI-I)
Time frame: Performed at each visit (weekly)
Young Mania Rating Scale (YMRS)
Time frame: Performed at each visit (weekly)
Hamilton-Anxiety Scale (HAM-A)
Time frame: Performed at each visit (weekly)
Reading Trust in the Mind's Eye Test
Time frame: Performed at the beginning and end of each treatment arm.
Profile of Mood States (POMS)
Time frame: Performed at the beginning and end of each treatment arm
Arizona Sexual Experience Scale (ASEX)
Time frame: Performed at each visit (weekly)
Peabody Picture Vocabulary Test
Time frame: Performed at the beginning of the study
California Verbal Learning Test
Time frame: Performed at the beginning and end of each treatment arm
Letter Number Sequencing Memory Test
Time frame: Performed at the beginning and end of each treatment arm
Continuous Performance Test (CPT)
Time frame: Performed at the beginning and end of each treatment arm
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.
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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 Major Depressive Disorder and Dysthymia Disorder, 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 12 inclusion and 6 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. Some participants in this study may receive a placebo. 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 on Montgomery-Asberg Depression Rating Score (MADRS) (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?
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.