Oxytocin Add-on for Stable Depressed Patients

NCT01211756 | Terminated Results

• 1 other identifier: Oxytocin Depression
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Dysthymia Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (12)

• Global Assessment of Functioning (GAF)

  Performed at each visit (weekly)

• Clinical Global Impression-Severity of Illness (CGI-S)

  Performed at each visit (weekly)

• Clinical Global Impression-Global Improvement (CGI-I)

  Performed at each visit (weekly)

• Young Mania Rating Scale (YMRS)

  Performed at each visit (weekly)

• Hamilton-Anxiety Scale (HAM-A)

  Performed at each visit (weekly)

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Oxytocin DRUG

20 IU BID for one week, followed by 40 IU BID for 3 weeks.

Oxytocin

Placebo DRUG

20 IU BID for one week, followed by 40 IU BID for 3 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• David Feifel: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Dysthymic Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.

Results Point of Contact

• Title: David Feifel
• Organization: UCSD

dfeifel@kadimanp.com

Study Officials

• David Feifel, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 25, 2019
• Results First Posted: September 25, 2019

Record last verified: 2016-12

Locations

US (1)