Trial Outcomes & Findings for Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction (NCT NCT00398632)

Last Updated: 2017-11-17

Results Overview

The GCI-I score is a global clinical impression score regarding a patient's symptom severity change rated by the treating clinician. The score can be 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse). In this study clinicians made ratings based on interviewing the patient and reviewing the patient's self ratings on the the Arizona Sexual Experiences Scale (ASEX). No formal cut point scores on the ASEX were established. The ASEX is a 5-item slef rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach organism, and satisfaction from orgasm. Each item is rated from 1 to 6 (total scores from 5 to 30), with higher scores indicating greater sexual dysfunction.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)

Results posted on

2017-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	Duloxetine Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression) Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Duloxetine Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression) Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks
Overall Study Withdrawal by Subject	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine n=6 Participants Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. study duration: 12 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Antidepressant taken prior to duloxetine switch venlafaxine	3 participants n=5 Participants
Antidepressant taken prior to duloxetine switch citalopram	2 participants n=5 Participants
Antidepressant taken prior to duloxetine switch fluoxetine	1 participants n=5 Participants
Clinically Depressed	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)

Population: Four subjects completed the study; two withdrew at end of week six. CGI-I ratings for two subjects were done at end of week 6 and this last observation was carried forward in the analysis. CGI-I ratings for the 4 completing subjects were done at end of week 12.

Outcome measures

Outcome measures
Measure	Duloxetine n=6 Participants Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression) Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks
Global Clinical Impressions Improvement Score re Sexual Functioning CGI sexual functioning much worse	1 participants
Global Clinical Impressions Improvement Score re Sexual Functioning CGI sexual functioning much improved	1 participants
Global Clinical Impressions Improvement Score re Sexual Functioning CGI sexual functioning minimally improved	3 participants
Global Clinical Impressions Improvement Score re Sexual Functioning CGi-I sexual functioning unchanged	1 participants

SECONDARY outcome

Timeframe: Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)

Population: All participants; the last observed non-missing value was used (LOCF)

The IDS-C is a 30-item inventory designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes. Scores less than or equal to 6 indicated remission in this study.

Outcome measures

Outcome measures
Measure	Duloxetine n=6 Participants Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression) Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks
Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study	5 Participants

Adverse Events

Duloxetine

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

Lorrin Koran, M.D., Professor of Psychiatry, Emeritus

Stanford University Medical Center, Department of Psychiatry

Phone: 650 498 5035

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place