Oxytocin Add-on for Stable Depressed Patients
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study of Intranasal Oxytocin Augmentation of Antidepressant Medication in Depressed Patients.|
- 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.
- Global Assessment of Functioning (GAF) [ Time Frame: Performed at each visit (weekly) ]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) ]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) ]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) ]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) ]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. ]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 ]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) ]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 ]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 ]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 ]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 ]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.
|Study Start Date:||October 2010|
|Study Completion Date:||December 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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.
20 IU BID for one week, followed by 40 IU BID for 3 weeks.
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.
20 IU BID for one week, followed by 40 IU BID for 3 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211756
|United States, California|
|UCSD Medical Center|
|San Diego, California, United States, 92103|
|Principal Investigator:||David Feifel, MD, PhD||University of California, San Diego|