Efficacy and Safety of IP2018 in Depressed, ED Patients
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial Studying the Efficacy and Safety of IP2018 in Depressed, Erectile Dysfunction (ED) Patients
IRAS ID
279910
Contact name
Robert Greenhalgh
Contact email
Sponsor organisation
Initiator Pharma A/S
Eudract number
2020-000469-18
Duration of Study in the UK
0 years, 7 months, 28 days
Research summary
Research Summary
The purpose of this study is to test a drug called IP2018 (the ‘study drug’) that is being developed for the treatment of depression and erectile dysfunction (ED).
The study drug is a new compound which works in a different way to current treatments by enhancing the effects of substances in the body such as serotonin and dopamine to help stimulate an erection. The study drug is being developed in the hope that it will treat depression and ED in men for whom current treatments either do not work or are poorly tolerated.The main aims of this study are:
• To assess the effect of the study drug on the body
• To assess the safety and tolerability of the study drug
• To see how the body absorbs and removes the study drugMale participants between the ages of 18 and 55 who suffer from mild to moderate depression and ED will be included. The study drug will be administered in 2 of the 3 treatment periods and placebo will be given in the remaining treatment period; ie, participants will be administered 1 (high) dose of study drug in 1 treatment period, 1 (low) dose of study drug in 1 treatment period and 1 dose of placebo in 1 treatment period. Two different dose levels of the study drug will be investigated (0.25 mg and 0.50 mg). The study is expected to last a total of seven weeks.
The aim of the study will be to look at the effect of the study drug on erectile function. A device applied to the penis will measure penile activity during a visual stimulus (erotic video).
Summary of results
The study was organised and funded by Initiator Pharma (the ‘Sponsor’) and was conducted by MAC Clinical Research in Manchester, United Kingdom, from November 2020 to March 2023.
Why was this study conducted?
The purpose of this study was to test a drug called IP2018 (the ‘study drug’) that is being developed for treating depression, low mood, and erectile dysfunction (ED).
Depression is a challenging mood disorder that affects people in different ways and causes many symptoms, such as unhappiness, feelings of worthlessness and hopelessness, loss of interest and anxiety. Symptoms can also be physical including constant tiredness, aches and pains and problems with sleep. If left untreated, depression may result in poor quality of life. For many people, the currently available antidepressant medications do not work well or cause side effects, resulting in some people not taking them.
Erectile dysfunction is the term used to describe when a man is unable to develop or sustain an erection, which can lead to difficulties in having sexual intercourse. The most common drugs currently available to treat ED, such as Viagra, work by relaxing the blood vessels in the penis so more blood can be entrapped in the penis to produce an erection. Although these drugs are effective in treating the condition in some men, for around 1 in 3 men, they do not work. Many men with depression also experience ED as part of the disease or as a side effect of their antidepressant medication.
The study drug works differently to current treatments by enhancing the effects of substances in the body such as serotonin and dopamine to help stimulate an erection. Serotonin and dopamine are neurotransmitters, which are chemical messengers responsible for sending messages or signals between brain cells. The study drug is being developed to treat depression and ED in men for whom current treatments either do not work or are poorly tolerated.
The main aims of this study were:
• To assess the effect of the study drug on the body using a visual sexual stimulation test
• To assess the safety and tolerability of the study drug
• To see how the body absorbs and removes the study drug
Who took part in the study?
Twenty-six male patients with a diagnosis of depression or low mood and ED were randomly divided into 3 groups. Twenty-four patients completed the study; two patients left it before it was completed.
Each patient who completed the study was administered:
• A low dose of IP2018
• A high dose of IP2018
• Placebo (a substance that looks like the study drug but does not contain the active ingredient)
What were the overall results of the study?
A single oral administration of the high dose of IP2018 increased penile tumescence (swelling) and duration of rigidity (stiffness) in a statistically significant way, sufficient for intercourse. The effect of IP2018 on erectile function was dose-dependent. The study demonstrated promising, clinically relevant efficacy data related to ED, supporting a new treatment model for this patient population.
Side effects are unwanted medical issues during the study that may or may not be related to the study drug. Some patients in this study experienced side effects, but no serious side effects or safety observations of concern were reported. Headache and gastrointestinal effects of mild severity were the most frequently reported side effects in this study.
How has this study helped patients and researchers?
This study was conducted on male patients aged 18 to 55 years with a diagnosis of depression or low mood and ED. The results from this study are limited to the particular people studied and cannot be assumed true for everybody. Not all patients in the study had the same results.
This research helps future patients and families by helping us understand more about the medicine being studied. Findings from this study will be used in other studies to compare this drug with other treatments for depression and ED.
Where can I find more information about this study?
To learn more about this study, visit http://www.clinicaltrials.gov.
This summary was completed on 24 October 2023. Newer information since this summary was written may now exist. This summary includes only results from one single study. Other studies may find different results.REC name
Wales REC 1
REC reference
20/WA/0114
Date of REC Opinion
26 Jun 2020
REC opinion
Further Information Favourable Opinion