Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

NCT00398632 | Terminated Phase 4 Results

• 1 other identifier: 97143
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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 are switched to duloxetine, and 2. they will experience either improved antidepressant response or no loss of antidepressant response.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  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

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

Study Arms (1)

Duloxetine

EXPERIMENTAL

Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)

Drug: Duloxetine

Interventions

Duloxetine DRUG

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

Also known as: Cymbalta

Duloxetine

Eligibility Criteria

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

You may qualify if:

• 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
• if currently taking medication to improve sexual performance, willing to discontinue the drug for the duration of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Open label trial, only six subjects enrolled, only 4 completed the trial

Results Point of Contact

• Title: Lorrin Koran, M.D., Professor of Psychiatry, Emeritus
• Organization: Stanford University Medical Center, Department of Psychiatry

lkoran@stanford.edu

650 498 5035

Study Officials

• Lorrin M Koran

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, Emeritus

Study Record Dates

• First Submitted: November 10, 2006
• First Posted: November 14, 2006
• Study Start: November 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 17, 2017
• Results First Posted: June 16, 2015

Record last verified: 2017-10

Locations

US (1)