Primary outcome· Performed at each visit (weekly)
Total Score on Montgomery-Asberg Depression Rating Score (MADRS)
| Group | Value |
|---|---|
| All Participants | not posted |
Trial · Interventional
TerminatedNot applicableResults postedRegistry dataOxytocin Add-on for Stable Depressed Patients
NCTNCT01211756 (opens ClinicalTrials.gov in a new tab)Other idOxytocin Depression
This trial was stopped early.
Reason given at the registry: Break in funding
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Not applicable
- Enrollment
- 1 participants (actual)
- Sponsor
- David Feifel · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- Oct 2010
- Primary completion
- Feb 2015
- Completion
- Dec 2015
- First posted
- 29 Sept 2010 (estimated)
- Last update posted
- 25 Sept 2019
- Conditions
- Major Depressive Disorder · Dysthymia Disorder
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2010201120122013201420152016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- OxytocinDrug
- PlaceboDrug
Arms2
Experimental
Oxytocin
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.
Placebo comparator
Placebo
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Total Score on Montgomery-Asberg Depression Rating Score (MADRS)
Time frame · Performed at each visit (weekly)
Registry description
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.
Secondary outcomes(12)
Global Assessment of Functioning (GAF)
Time frame · Performed at each visit (weekly)
Registry description
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).
Clinical Global Impression-Severity of Illness (CGI-S)
Time frame · Performed at each visit (weekly)
Registry description
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).
Clinical Global Impression-Global Improvement (CGI-I)
Time frame · Performed at each visit (weekly)
Registry description
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).
Young Mania Rating Scale (YMRS)
Time frame · Performed at each visit (weekly)
Registry description
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.
Hamilton-Anxiety Scale (HAM-A)
Time frame · Performed at each visit (weekly)
Registry description
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).
Reading Trust in the Mind's Eye Test
Time frame · Performed at the beginning and end of each treatment arm.
Registry description
The subject will view approximately 16 faces and asked to rate trustfulness of the person in the picture.
Profile of Mood States (POMS)
Time frame · Performed at the beginning and end of each treatment arm
Registry description
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.
Arizona Sexual Experience Scale (ASEX)
Time frame · Performed at each visit (weekly)
Registry description
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.
Peabody Picture Vocabulary Test
Time frame · Performed at the beginning of the study
Registry description
The subject is read a series of words and is shown line drawings and is asked to match the word to the drawing.
California Verbal Learning Test
Time frame · Performed at the beginning and end of each treatment arm
Registry description
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.
Letter Number Sequencing Memory Test
Time frame · Performed at the beginning and end of each treatment arm
Registry description
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.
Continuous Performance Test (CPT)
Time frame · Performed at the beginning and end of each treatment arm
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcome· Performed at each visit (weekly)
Global Assessment of Functioning (GAF)
| Group | Value |
|---|---|
| All Participants | not posted |
Secondary outcome· Performed at each visit (weekly)
Clinical Global Impression-Severity of Illness (CGI-S)
| Group | Value |
|---|---|
| All Participants | not posted |
Secondary outcome· Performed at each visit (weekly)
Clinical Global Impression-Global Improvement (CGI-I)
| Group | Value |
|---|---|
| All Participants | not posted |
Secondary outcome· Performed at each visit (weekly)
Young Mania Rating Scale (YMRS)
| Group | Value |
|---|---|
| All Participants | not posted |
Secondary outcome· Performed at each visit (weekly)
Hamilton-Anxiety Scale (HAM-A)
| Group | Value |
|---|---|
| All Participants | not posted |
Secondary outcome· Performed at the beginning and end of each treatment arm.
Reading Trust in the Mind's Eye Test
| Group | Value |
|---|---|
| All Participants | not posted |
Secondary outcome· Performed at the beginning and end of each treatment arm
Profile of Mood States (POMS)
| Group | Value |
|---|---|
| All Participants | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| All ParticipantsAs there was only one subject enrolled, the results will not be analyzed. | 0 / 0 | 0 / 0 | 0 / 0 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Adult men or women, 18 years of age or older.
2. Meet DSM-IV criteria for Major Depressive Disorder or Dysthymia Disorder
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 1 or 2 antidepressants with no major dose changes for at least 4 weeks at randomization.
5. MADRS score of \>17 at randomization
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. (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.
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 Major Depressive Disorder or Dysthymia Disorder
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