Not provided
Not provided
Not provided
Not provided
Not provided
Break in funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 20 IU BID for one week, followed by 40 IU BID for 3 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Performed at each visit (weekly) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Performed at each visit (weekly) |
| Clinical Global Impression-Severity of Illness (CGI-S) |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Feifel, MD, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | San Diego | California | 92103 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | As there was only one subject enrolled, the results will not be analyzed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | As there was only one subject enrolled, the results will not be analyzed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at each visit (weekly) |
|
|
Not provided
The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | As there was only one subject enrolled, the results will not be analyzed. |
Not provided
Not provided
The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Feifel | UCSD | dfeifel@kadimanp.com |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019263 | Dysthymic Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
20 IU BID for one week, followed by 40 IU BID for 3 weeks. |
|
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). |
| 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). | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Performed at the beginning and end of each treatment arm |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| Participants |
|
| Secondary | 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). | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at each visit (weekly) |
|
|
| Secondary | 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). | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at each visit (weekly) |
|
|
| Secondary | 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). | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at each visit (weekly) |
|
|
| Secondary | 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. | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at each visit (weekly) |
|
|
| Secondary | 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). | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at each visit (weekly) |
|
|
| Secondary | 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. | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at the beginning and end of each treatment arm. |
|
|
| Secondary | 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. | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at the beginning and end of each treatment arm |
|
|
| Secondary | 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. | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at each visit (weekly) |
|
|
| Secondary | 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. | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at the beginning of the study |
|
|
| Secondary | 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. | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at the beginning and end of each treatment arm |
|
|
| Secondary | 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. | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at the beginning and end of each treatment arm |
|
|
| Secondary | 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. | The PI has left the institution and there was only one subject enrolled, the results will not be analyzed. | Posted | Performed at the beginning and end of each treatment arm |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
Not provided
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |