DepressionPhase 4NCT00398632

Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

A Phase 4 study testing Duloxetine in people with Depression, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors (SSRIs). The hypotheses of this study are that:1. subjects with major depression or dysthymia who are being treated with an SSRI and experiencing treatment-related sexual dysfunction will experience less sexual dysfunction if they… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression
What is being tested?: Duloxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Nov 2006to Apr 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age 18 - 65 inclusive
able to read and understand informed consent
informed consent given
currently being treated with an SSRI for depression or dysthymia
currently suffering from treatment-emergent sexual dysfunction attributable to the SSRI
have normal safety lab values at screen

Show all 16Show fewer

if currently taking medication to improve sexual performance, willing to discontinue the drug for the duration of the study
female subjects of child bearing age need to use an acceptable form of birth control throughout the study Exclusion Criteria:- being pregnant, breastfeeding, or planning to become pregnant within 4 months
suffering from psychotic, substance abuse, bipolar, or organic mental disorder, OCD, panic disorder, or personality disorder severe enough to interfere with study participation
suffer from an unstable or serious medical disorder
having a medical disorder that could be the cause of the sexual dysfunction
taking a medication that is metabolized by hepatic enzyme CYP2D6
having used a MAOI within 15 days of proposed start of duloxetine treatment
having a known hypersensitivity to duloxetine or any of its ingredients
having taken viagra or related drug within 3 months prior to starting SSRI treatment
requiring ongoing treatment with a mood stabilizer (anticonvulsant) or antipsychotic medication

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

Read the detailed description

In this study, subjects suffering from depression or dysthymia and experiencing treatment-emergent sexual dysfunction from an SSRI are switched from their SSRI to duloxetine to determine whether or not they experience improved sexual function and equal or improved antidepressant response. Study subjects are assigned to receive open label duloxetine for 12 weeks at either 60mg per day or 120mg per day after discontinuing their current antidepressant

Conditions: Depression
Being tested: Duloxetine
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DuloxetineDrug
Also called Cymbalta
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

Study groups in NCT00398632
Study group	Role	What they receive
Duloxetine	Experimental	Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression) Receives: Drug: Duloxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

Global Clinical Impressions Improvement Score re Sexual Functioning
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.
Measured: baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)

Secondary outcomes (1)

Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study
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.
Measured: Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Apr 2009

First posted14 Nov 2006 (estimated)
Study startNov 2006
Primary completionApr 2009
Study completionApr 2009

Why it stopped: Unable to recruit subjects

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00398632
Sponsor's protocol ID: 97143
Status last verified: Oct 2017
First submitted: 10 Nov 2006
Last updated: 17 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction
ClinicalTrials.gov ID: NCT00398632
Acronym / sponsor ID: 97143
Conditions: Depression
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unable to recruit subjects
Enrolment: 6 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Eli Lilly and Company
Study start: Nov 2006
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 14 Nov 2006 (estimated)
Results: Posted 16 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Duloxetine	Experimental	Drug: DuloxetineDuloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

age 18 - 65 inclusive
able to read and understand informed consent
informed consent given
currently being treated with an SSRI for depression or dysthymia
currently suffering from treatment-emergent sexual dysfunction attributable to the SSRI

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DuloxetineAlso: Cymbaltadosage 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	Drug	Duloxetine

Primary outcome

Global Clinical Impressions Improvement Score re Sexual Functioning
Time frame: baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)
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.

1 secondary outcome

Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study
Time frame: Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)

Results and safety

Results posted to the registry on 16 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Duloxetine	6	4

Primary outcome: Global Clinical Impressions Improvement Score re Sexual Functioning

Time frame: baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6). Number. Unit: participants

Measure	Duloxetine n = 6
CGI sexual functioning much improved	1
CGI sexual functioning minimally improved	3
CGi-I sexual functioning unchanged	1
CGI sexual functioning much worse	1

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Duloxetine	0 of 6 (0%)	0 of 6 (0%)	Not reported

Limitations and caveats (from the sponsor): Open label trial, only six subjects enrolled, only 4 completed the trial

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lorrin M Koran principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Duloxetine in people with Depression, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Clinical Impressions Improvement Score re Sexual Functioning (time frame: baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00398632.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.