Trial Outcomes & Findings for Insulin Resistance in Patients With Mood Disorder (NCT NCT00242619)

Results Overview

The Hamilton Depression Rating Scale (HDRS-21) measures depression severity on a scale from 0 to 21, with 0 being the lowest level of depression severity and 21 being the highest level of depression severity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	Completers Subjects who completed the study and 12 weeks of taking rosiglitazone.	Drop-Outs Subjects who dropped out and did not complete the 12 weeks on rosiglitazone.
Overall Study STARTED	8	4
Overall Study COMPLETED	8	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insulin Resistance in Patients With Mood Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Completers n=8 Participants Subjects who met all criteria, took rosiglitazone, and completed the study.	Drop-Outs n=4 Participants Subjects who met all criteria, took rosiglitazone, and did not complete the study.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51.9 years STANDARD_DEVIATION 5.6 • n=5 Participants	52.0 years STANDARD_DEVIATION 6.5 • n=7 Participants	51.95 years STANDARD_DEVIATION 6.05 • n=5 Participants
Gender Female	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	4 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

The Hamilton Depression Rating Scale (HDRS-21) measures depression severity on a scale from 0 to 21, with 0 being the lowest level of depression severity and 21 being the highest level of depression severity.

Outcome measures

Outcome measures
Measure	Completers n=8 Participants Subjects who completed the study.	Drop-Outs n=4 Participants Subjects who dropped out of the study.
Hamilton Depression Rating Scale (HDRS-21)	19.9 units on a scale Standard Deviation 5.0	13.0 units on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: 12 weeks

The Clinical Global Impression-Severity Scale (CGI-S) assesses depression severity. It is a 7-point scale, where 1 is the lowest level of depression severity and 7 is the highest level of depression severity.

Outcome measures

Outcome measures
Measure	Completers n=8 Participants Subjects who completed the study.	Drop-Outs n=4 Participants Subjects who dropped out of the study.
Clinical Global Impression-Severity Scale (CGI-S)	4.1 units on a scale Standard Deviation 0.6	3.3 units on a scale Standard Deviation 0.5

Adverse Events

Completers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Drop-Outs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Natalie Rasgon

Stanford University

Phone: (650) 724-6689

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place