Trial Outcomes & Findings for Oxytocin Add-on for Stable Depressed Patients (NCT NCT01211756)
NCT ID: NCT01211756
Last Updated: 2019-09-25
Results Overview
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.
TERMINATED
NA
1 participants
Performed at each visit (weekly)
2019-09-25
Participant Flow
Participant milestones
| Measure |
All Participants
As there was only one subject enrolled, the results will not be analyzed.
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|---|---|
|
Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin Add-on for Stable Depressed Patients
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Performed at each visit (weekly)Population: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at each visit (weekly)Population: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at each visit (weekly)Population: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at each visit (weekly)Population: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at each visit (weekly)Population: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at each visit (weekly)Population: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at the beginning and end of each treatment arm.Population: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
The subject will view approximately 16 faces and asked to rate trustfulness of the person in the picture.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at the beginning and end of each treatment armPopulation: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at each visit (weekly)Population: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at the beginning of the studyPopulation: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
The subject is read a series of words and is shown line drawings and is asked to match the word to the drawing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at the beginning and end of each treatment armPopulation: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at the beginning and end of each treatment armPopulation: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Performed at the beginning and end of each treatment armPopulation: The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.
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.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place