Phase 2 Completed N=99 Randomized Double-blind Treatment

Safety and Efficacy Study in Patients With Major Depressive Disorder

Source: ClinicalTrials.gov NCT00896363 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcomePrimary: Change From Baseline in the Hamilton Depression Rating Scale (HAMD17), on Day 14 and 42 — -10.9; -10.8; -10.3; -18.6 Score on scale

Summary

The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The safety and how well the body can handle the drug will also be investigated. The study will be conducted in Russia in hospitalised patients with severe depression. GSK163090 will be compared with placebo, which looks like the study drug but does not contain any active substance. Subjects will be given either the study drug or the matching placebo.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Hamilton Depression Rating Scale (HAMD17), on Day 14 and 42	-10.9; -10.8; -10.3; -18.6; -18.4; -16.7	—
PRIMARY Change From Baseline in Bech Melancholia Subscale (BECH 6) Scale, on Day 14 and 42	-4.9; -4.6; -4.2; -8.7; -8.4; -7.8	—
PRIMARY Change From Baseline in Quick Inventory of Depressive Symtomatology - Self Rated (QIDS-SR) Scale, on Day 14 and 42	-6.2; -6.1; -6.5; -11.0; -11.4; -10.8	—
PRIMARY Number of Participants With Suicidal Behavior and Suicidal Ideation Subscales of the Columbia Suicide Severity Rating Scale (C-SSRS)	0; 0; 0; 7; 5; 4	—
PRIMARY Number of Participants With Abnormal Hematology Values of Clinical Concern Range (CCR).	2; 0; 0; 2; 0; 0	—
PRIMARY Number of Participants With Abnormal Chemistry Values of CCR	0; 1; 1; 1; 1; 0	—
PRIMARY Change From Baseline in Liver Chemistry -Alkaline Phosphatase (ALP), ALT, AST and GGT	2.8; -6.6; -1.7; 4.6; 2.5; -5.4	—
PRIMARY Change From Baseline in Liver Chemistry- Direct Bilirubin and Total Bilirubin	0.59; 0.13; 0.38; 0.61; -0.14; 0.25	—
PRIMARY Number of Participant of Urinanalysis Assessment Over Period	2; 2; 1; 4; 0; 2	—
PRIMARY Change From Baseline in Electrocardiogram (ECG) Values -PR Interval, QRS Duration, QT Interval, QTcB, QTcF, RR Interval	149.9; 148.2; 158.7; 156.4; 159.2; 163.6	—
PRIMARY Mean of Change From Baseline in Systolic and Diastolic Blood Pressure (BP)	120.6; 120.3; 120.9; -0.8; 0.1; 1.5	—
PRIMARY Mean of Change From Baseline in Heart Rate	73.0; 73.3; 71.8; 1.4; 1.0; 1.1	—
PRIMARY Number of Participants With All Adverse Events (AEs), and Serious Adverse Events (SAEs)	17; 24; 14; 0; 0; 0	—
SECONDARY Mean Last Observed Quantifiable Concentration (Ct) of GSK163090 Over the Period	0.951; 3.239	—
SECONDARY Area Under Concentration-time Curve (AUC) at Steady State	—	—
SECONDARY Average Concentration (Cave) at Steady State	—	—
SECONDARY Preliminary Pharmacokinetic/ Pharmacodynamic (PK/PD)Relationships for GSK163090 in Participants With MDD.	—	—

Eligibility Criteria

Inclusion Criteria

Currently have severe depression (Major Depressive Disorder - without psychotic features)
meet criteria (DSM IV-TR ) for current major depressive episode for at least 4 weeks but for no greater than 24 months
depression questionnaire (HAMD17) total score greater than or equal to 24
subject must read and able to give written informed consent
male or female 18 to 64 years
use appropriate birth control method
BMI 18.8 - 35.0 kg/m2 (inclusive)

Exclusion Criteria

Primary diagnosis of other psychiatric disorders
thoughts of killing ones self or someone else
taking psychiatric medicine or therapy within the six months
Has previously failed an adequate course of medication for MDD from two different classes of antidepressants.
Unstable medical disorder or a disorder that would interfere with the action of the drug
Abuse of alcohol or drugs
Past history of serotonin syndrome or a history of clinical significant intolerance of SSRIs (class of drugs used for depression).
History of migraine headaches that respond to treatment with triptan medication.
History of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
Currently taking part in another clinical study or has done so within six months
Pregnant, planning to become pregnant shortly or breastfeeding
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00896363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.