Study to Assess Clinical Response of Duloxetine in Patients Hospitalized for Severe Depression

NCT02229825 | Completed Phase 4 Results

• 1 other identifier: 1208.24
• Study Type: interventional
• Target: 339
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized for severe depression after 4 weeks of treatment. To evaluate the rescue option in non-responding patients. Safety of Duloxetine will also be assessed.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4

  The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) scored from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).

  At baseline and at Week 4.

Secondary Outcomes (25)

• Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4

  At baseline and at Week 1, 2, 3 and Week 4.

• Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups

  At baseline and at Week 6 and Week 8.

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3

  At baseline and at Week 1, 2 and Week 3.

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups

  At baseline and at Week 6 and Week 8.

• Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale

  At week 1, 2, 3 and week 4.

Study Arms (2)

Duloxetine 60 mg

EXPERIMENTAL

Duloxetine 60 mg

Drug: Duloxetine; Drug: Placebo

Duloxetine 120 mg

EXPERIMENTAL

Duloxetine 120 mg

Drug: Duloxetine; Drug: Placebo

Interventions

Duloxetine DRUG

Capsule

Duloxetine 120 mg; Duloxetine 60 mg

Placebo DRUG

Capsule

Duloxetine 120 mg; Duloxetine 60 mg

Eligibility Criteria

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

You may qualify if:

• Male or female patients of 18 years of age at the screening visit or older
• Meet criteria for severe Major Depressive Disorder (MDD)
• Montgomery-Asberg-depression rating scale (MADRS) total score ≥ 30 and the 6-item Hamilton Depression scale (HAMD-6) score ≥12 at both screening (V1) visit and baseline (V2) visits
• Clinical Global Impression of Severity (CGI-Severity) score ≥4 at both screening visit and baseline visit.
• Requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to Visit 4
• Patient willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol
• Have a level of understanding sufficient to provide informed consent and to communicate with the investigators and site personnel. Informed consent document must be signed at screening visit, in accordance with Good Clinical Practice (GCP) and local regulatory requirements, prior to any study procedure

You may not qualify if:

• More than two previous episodes of major depression that did not respond to adequate doses and duration (minimum of 6 weeks) of two different antidepressant therapies
• Lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode
• Concurrent presence of symptoms fulfilling criteria for any Axis I disorder other than anxiety disorders (with exception of the Obsessive-Compulsive Disorder (OCD)) or Major Depressive Disorder, in the investigator's judgment
• Any previous diagnosis of a bipolar disorder, schizophrenia or OCD
• Depression with catatonic features, depression with post-partum onset, or organic mental disorders
• The presence of an Axis II disorder
• MDD with psychotic features requiring neuroleptic treatment and/or interfering with patient's ability to provide informed consent, at investigator's discretion
• History of substance abuse or dependence within the past year, excluding nicotine and caffeine, but including alcohol or benzodiazepines
• Positive urine screen for drug abuse (cannabinoids, cocaine, opiates including methadone, or amphetamines) at screening
• Epilepsy or a history of seizure disorder or of a treatment with anticonvulsant medication for epilepsy or seizures
• Patients with acute liver injury (such as hepatitis) or severe cirrhosis (such as Child-Pugh Class C)
• Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption syndrome, or lactose deficiency
• Patient with a known diagnosis of raised intraocular pressure, or at known risk of acute narrow-angle glaucoma
• End stage renal disease (estimated creatinine clearance ≤30 mL/min) and undergoing dialysis
• Abnormal thyroid-stimulating hormone (TSH) concentrations, based on the performing laboratory's reference ranges. Patients must be clinically and chemically euthyroid at the time of randomization. Patients may be taking thyroid replacement therapy provided their dose is stable and their compliance is good for at least three months before the screening visit

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: February 9, 2007
• Primary Completion: August 26, 2008
• Study Completion: August 26, 2008
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-10