Back to resultsOxytocin Add-on for Stable Depressed Patients
Primary Purpose
Major Depressive Disorder, Dysthymia Disorder
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
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
Sites / Locations
- UCSD Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxytocin
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
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).
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.
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).
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01211756
Brief Title
Oxytocin Add-on for Stable Depressed Patients
Official Title
Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study of Intranasal Oxytocin Augmentation of Antidepressant Medication in Depressed Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Break in funding
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Feifel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Dysthymia Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
20 IU BID for one week, followed by 40 IU BID for 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
20 IU BID for one week, followed by 40 IU BID for 3 weeks.
Primary Outcome Measure Information:
Title
Total Score on Montgomery-Asberg Depression Rating Score (MADRS)
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.
Time Frame
Performed at each visit (weekly)
Secondary Outcome Measure Information:
Title
Global Assessment of Functioning (GAF)
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).
Time Frame
Performed at each visit (weekly)
Title
Clinical Global Impression-Severity of Illness (CGI-S)
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).
Time Frame
Performed at each visit (weekly)
Title
Clinical Global Impression-Global Improvement (CGI-I)
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).
Time Frame
Performed at each visit (weekly)
Title
Young Mania Rating Scale (YMRS)
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.
Time Frame
Performed at each visit (weekly)
Title
Hamilton-Anxiety Scale (HAM-A)
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).
Time Frame
Performed at each visit (weekly)
Title
Reading Trust in the Mind's Eye Test
Description
The subject will view approximately 16 faces and asked to rate trustfulness of the person in the picture.
Time Frame
Performed at the beginning and end of each treatment arm.
Title
Profile of Mood States (POMS)
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.
Time Frame
Performed at the beginning and end of each treatment arm
Title
Arizona Sexual Experience Scale (ASEX)
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.
Time Frame
Performed at each visit (weekly)
Title
Peabody Picture Vocabulary Test
Description
The subject is read a series of words and is shown line drawings and is asked to match the word to the drawing.
Time Frame
Performed at the beginning of the study
Title
California Verbal Learning Test
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.
Time Frame
Performed at the beginning and end of each treatment arm
Title
Letter Number Sequencing Memory Test
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.
Time Frame
Performed at the beginning and end of each treatment arm
Title
Continuous Performance Test (CPT)
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.
Time Frame
Performed at the beginning and end of each treatment arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Feifel, MD, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Oxytocin Add-on for Stable Depressed Patients
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