Major Depressive DisorderPhase 4SCENCT03131050
Effectiveness Study of Scopolamine Combined With Escitalopram in Patients With MDD
A Phase 4 study testing Scopolamine, Escitalopram and Saline in people with Major Depressive Disorder, run by Capital Medical University at 1 site in China.
Trial summary
Despite the availability of a wide range of antidepressant drugs, clinical trials indicate that 30% to 40% of patients with major depression fail to respond to first-line antidepressant treatment, despite adequate dosage, duration, and compliance. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Scopolamine, Escitalopram and Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2017to 8 Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has given written informed consent.
- Male or female outpatients aged at least 18 years and not more than 45 years.
- Has a diagnosis of major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
- Current HAMD-17 score ≥ 20 and the duration of the index episode is greater than or equal to four weeks.
Who cannot join
- Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug.
- Current Axis I primary psychiatric diagnosis other than major depressive disorder.
- Organic mental disease, including mental retardation.
- History of clinically significant disease, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require treatment during the study.
- Subjects receiving an investigational agent (including different formulation and generic agents of investigational drug) in the previous 3 months prior to screening.
- Women in pregnancy or lactation, or female of child bearing potential without appropriate birth control measures.
Show all 13Show fewer
- Use of antipsychotics or mood stabilizers within 5 days prior to screening.
- Has received depot antipsychotic medication within one cycle prior to screening.
- Known allergy or lack of response to mirtazapine.
- Has received ECT or MECT within 3 months prior to screening.
- History of anticholinergic drug allergy or complications (allergic reaction, skin rash, urticaria and other allergic reactions which caused by drugs).
- Smokers.
- Significant risk of suicidal and/or self-harm behaviors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Controlled, Randomized Study Comparing Escitalopram Combined With Scopolamine or Escitalopram in Patients With Major Depressive Disorder
Despite the availability of a wide range of antidepressant drugs, clinical trials indicate that 30% to 40% of patients with major depression fail to respond to first-line antidepressant treatment, despite adequate dosage, duration, and compliance. Moreover, in those patients who do experience symptomatic relief following conventional anti-depressant treatment, clinical improvement is not evident for 3-4 weeks. Thus, there is a clear need to develop novel and improved therapeutics for unipolar depression.
A previous study showed that the intravenous administration of scopolamine produces antidepressant effects. This study is designed to determine if scopolamine combine with Escitalopram produce antidepressant effects at an early stage.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial. Sixty-six outpatients (ages 18-45) with severe major depressive disorder (MDD) (17-item Hamilton Rating Scale for Depression total score greater than or equal to 20) are enrolled from Beijing Anding Hospital. All participants receive oral escitalopram 10 mg/d throughout the total of 4 weeks treatment. Meanwhile, they are randomized equally to one of three add-on treatment arms during the first three days: (1) intramuscular injection (i.m.) with saline (1 ml) at 9 am and 3 pm per day; (2) scopolamine (0.3 mg in 1ml saline, i.m.) at 9 am and saline (1 ml, i.m.) at 3 pm per day; (3) scopolamine (0.3 mg in 1ml saline, i.m.) at 9 am and 3 pm per day, respectively. Patients were assessed at baseline, day 2, day 3, day 4, day 7, day 14, and day 28 using 17-Item Hamilton Depression Rating Scale(HAMD-17), Montgomery-Asberg Depression Rating Scale(MADRS), Young Mania Rating Scale(YMRS), Generalized Anxiety Disorder-7(GAD-7), Quick Inventory of Depressive Symptomatology Self-report 16(QIDS-SR16) and Clinical Global Impression(CGI) by assessors masked to treatment assignments. The primary outcome measure was the time from randomization (baseline) to early improvement (at least 20% reduction in HAMD-17 score ). The second outcome measures were response rates (at least 50% decrease in the HAMD-17 at any visit from baseline), remission rate (HAMD-17 score≤7) at day 28, change in HAMD-17 score ,MADRS score, QIDS-SR16 score, GAD7 score and YMRS score from baseline to any visit, change in CGI-S from baseline to the end of the trial, and CGI-I score at any visit.
- Conditions
- Major Depressive Disorder
- Being tested
- Scopolamine, Escitalopram, Saline
- Keywords
- Scopolamine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScopolamineDrug
Intramuscular injection with scopolamine (0.3 mg/1ml,QD or Bid) during the first three days;
EscitalopramDrug
Oral escitalopram 10 mg/d throughout the total of 4 weeks treatment
SalineDrug
Intramuscular injection with saline (1ml, QD or Bid) during the first three days;
| Study group | Role | What they receive |
|---|---|---|
| High-dose scopolamine add-on therapy | Experimental | Scopolamine (0.3 mg/1 ml, i.m.) Bid; escitalopram （10 mg/d p.o.）QD Receives: Drug: Scopolamine; Drug: Escitalopram |
| Low-dose scopolamine add-on therapy | Experimental | Scopolamine (0.3 mg/1 ml, i.m.) QD; placebo (1 ml saline, i.m.) QD; escitalopram （10 mg/d p.o.）QD Receives: Drug: Scopolamine; Drug: Escitalopram; Drug: Saline |
| Placebo add-on therapy | Placebo comparator | Placebo (1 ml saline, i.m.) Bid; escitalopram （10 mg/d p.o.）QD Receives: Drug: Escitalopram; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of early onset
The time from randomization (baseline) to early improvement (at least 20% reduction in HAMD-17 score )
Measured: From randomization (base line) to endpoint(Week 4)
Secondary outcomes (8)
Response rate of patients receiving scopolamine
The proportion of subjects with at least 50% decrease in the HAMD-17 at any visit from baseline.Response was defined as ≥50% decrease in the baseline HAMD-17 total scores.
Measured: From randomization (base line) to endpoint(Week 4)
The proportion of subjects at endpoint with HAMD-17≤7
Remission was defined as the HAMD total score ≤7
Measured: endpoint(Week 4)
Change in 17-item Hamilton Depression Scale (HAMD-17) scores
Change in HAMD-17 scores measured by the difference between baseline HAMD-17 score and HAMD-17 score at endpoint.
Measured: From randomization (base line) to endpoint(Week 4)
Change in Montgomery-Asberg Depression Rating Scale(MADRS)
Change in MADRS scores measured by the difference between baseline MADRS score and MADRS score at endpoint.
Measured: From randomization (base line) to endpoint(Week 4)
Change in QIDS-SR16 score
Change in QIDS-SR16 score measured by the difference between baseline QIDS-SR16 score and QIDS-SR16 score at endpoint.
Measured: From randomization (base line) to endpoint(Week 4)
Change in GAD7 score
Change in GAD7 score measured by the difference between baseline GAD7 score and GAD7 score at endpoint.
Measured: From randomization (base line) to endpoint(Week 4)
Change in YMRS score
Change in YMRS score measured by the difference between baseline YMRS score and YMRS score at endpoint.
Measured: From randomization (base line) to endpoint(Week 4)
Change in CGI-S score
Change in CGI-S score measured by the difference between baseline CGI-S score and CGI-S score at endpoint.
Measured: From randomization (base line) to endpoint(Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start15 Mar 2017
- Primary completion8 Feb 2018
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Capital Medical 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- GROUP 1: The patients received intramuscular injection treatment of scopolamine (0.3 mg/ml) at 9 am and 0.9% saline treatment at 3pm. GROUP 2: The patients received intramuscular injection treatment of scopolamine (0.3 mg/ml) at 9 am and 3 PM. GROUP 3: The patients received intramuscular injection treatment of 0.9% saline (1 ml) at 9 am and 3 PM.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wang, MD, Capital Medical University
- Investigators
- Gang Wang, M.D.,Ph.D., Principal investigator, Beijing Anding Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131050
- Sponsor's protocol ID
- Scopolamine i.m.
- Acronym
- SCE
- Status last verified
- Dec 2018
- First submitted
- 18 Apr 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Furey ML, Drevets WC. Antidepressant efficacy of the antimuscarinic drug scopolamine: a randomized, placebo-controlled clinical trial. Arch Gen Psychiatry. 2006 Oct;63(10):1121-9. doi: 10.1001/archpsyc.63.10.1121.
PubMed 17015814Zhou J, Yang J, Zhu X, Zghoul T, Feng L, Chen R, Wang G. The effects of intramuscular administration of scopolamine augmentation in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled trial. Ther Adv Psychopharmacol. 2020 Jul 1;10:2045125320938556. doi: 10.1177/2045125320938556. eCollection 2020.
PubMed 32655854Zhou J, Wang W, Yang J, Zhu X, Feng L, Xiao L, Wang G. Scopolamine augmentation of a newly initiated escitalopram treatment for major depressive disorder: study protocol for a randomized controlled trial. Trials. 2019 Jan 9;20(1):33. doi: 10.1186/s13063-018-3132-3.
PubMed 30626409
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Controlled, Randomized Study Comparing Escitalopram Combined With Scopolamine or Escitalopram in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03131050
- Acronym / sponsor ID
- SCE / Scopolamine i.m.
- Conditions
- Major Depressive Disorder
- Keywords
- Scopolamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the availability of a wide range of antidepressant drugs, clinical trials indicate that 30% to 40% of patients with major depression fail to respond to first-line antidepressant treatment, despite adequate dosage, duration, and compliance. Moreover, in those patients who do experience symptomatic relief following conventional anti-depressant treatment, clinical improvement is not evident for 3-4 weeks. Thus, there is a clear need to develop novel and improved therapeutics for unipolar depression.
A previous study showed that the intravenous administration of scopolamine produces antidepressant effects. This study is designed to determine if scopolamine combine with Escitalopram produce antidepressant effects at an early stage.
Detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial. Sixty-six outpatients (ages 18-45) with severe major depressive disorder (MDD) (17-item Hamilton Rating Scale for Depression total score greater than or equal to 20) are enrolled from Beijing Anding Hospital. All participants receive oral escitalopram 10 mg/d throughout the total of 4 weeks treatment. Meanwhile, they are randomized equally to one of three add-on treatment arms during the first three days: (1) intramuscular injection (i.m.) with saline (1 ml) at 9 am and 3 pm per day; (2) scopolamine (0.3 mg in 1ml saline, i.m.) at 9 am and saline (1 ml, i.m.) at 3 pm per day; (3) scopolamine (0.3 mg in 1ml saline, i.m.) at 9 am and 3 pm per day, respectively. Patients were assessed at baseline, day 2, day 3, day 4, day 7, day 14, and day 28 using 17-Item Hamilton Depression Rating Scale(HAMD-17), Montgomery-Asberg Depression Rating Scale(MADRS), Young Mania Rating Scale(YMRS), Generalized Anxiety Disorder-7(GAD-7), Quick Inventory of Depressive Symptomatology Self-report 16(QIDS-SR16) and Clinical Global Impression(CGI) by assessors masked to treatment assignments. The primary outcome measure was the time from randomization (baseline) to early improvement (at least 20% reduction in HAMD-17 score ). The second outcome measures were response rates (at least 50% decrease in the HAMD-17 at any visit from baseline), remission rate (HAMD-17 score≤7) at day 28, change in HAMD-17 score ,MADRS score, QIDS-SR16 score, GAD7 score and YMRS score from baseline to any visit, change in CGI-S from baseline to the end of the trial, and CGI-I score at any visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- GROUP 1: The patients received intramuscular injection treatment of scopolamine (0.3 mg/ml) at 9 am and 0.9% saline treatment at 3pm. GROUP 2: The patients received intramuscular injection treatment of scopolamine (0.3 mg/ml) at 9 am and 3 PM. GROUP 3: The patients received intramuscular injection treatment of 0.9% saline (1 ml) at 9 am and 3 PM.
| Arm | Type | Receives |
|---|---|---|
| High-dose scopolamine add-on therapy | Experimental | Drug: Scopolamine, Drug: EscitalopramScopolamine (0.3 mg/1 ml, i.m.) Bid; escitalopram （10 mg/d p.o.）QD |
| Low-dose scopolamine add-on therapy | Experimental | Drug: Scopolamine, Drug: Escitalopram, Drug: SalineScopolamine (0.3 mg/1 ml, i.m.) QD; placebo (1 ml saline, i.m.) QD; escitalopram （10 mg/d p.o.）QD |
| Placebo add-on therapy | Placebo comparator | Drug: Escitalopram, Drug: SalinePlacebo (1 ml saline, i.m.) Bid; escitalopram （10 mg/d p.o.）QD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Has given written informed consent.
- Male or female outpatients aged at least 18 years and not more than 45 years.
- Has a diagnosis of major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
- Current HAMD-17 score ≥ 20 and the duration of the index episode is greater than or equal to four weeks.
Key exclusion criteria (13 listed)
- Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug.
- Current Axis I primary psychiatric diagnosis other than major depressive disorder.
- Organic mental disease, including mental retardation.
- History of clinically significant disease, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require treatment during the study.
- Subjects receiving an investigational agent (including different formulation and generic agents of investigational drug) in the previous 3 months prior to screening.
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 |
|---|---|---|
| ScopolamineIntramuscular injection with scopolamine (0.3 mg/1ml,QD or Bid) during the first three days; | Drug | High-dose scopolamine add-on therapy, Low-dose scopolamine add-on therapy |
| EscitalopramOral escitalopram 10 mg/d throughout the total of 4 weeks treatment | Drug | High-dose scopolamine add-on therapy, Low-dose scopolamine add-on therapy, Placebo add-on therapy |
| SalineIntramuscular injection with saline (1ml, QD or Bid) during the first three days; | Drug | Low-dose scopolamine add-on therapy, Placebo add-on therapy |
Primary outcome
The time of early onset
Time frame: From randomization (base line) to endpoint(Week 4)
The time from randomization (baseline) to early improvement (at least 20% reduction in HAMD-17 score )
8 secondary outcomes
Response rate of patients receiving scopolamine
Time frame: From randomization (base line) to endpoint(Week 4)
The proportion of subjects at endpoint with HAMD-17≤7
Time frame: endpoint(Week 4)
Change in 17-item Hamilton Depression Scale (HAMD-17) scores
Time frame: From randomization (base line) to endpoint(Week 4)
Change in Montgomery-Asberg Depression Rating Scale(MADRS)
Time frame: From randomization (base line) to endpoint(Week 4)
Change in QIDS-SR16 score
Time frame: From randomization (base line) to endpoint(Week 4)
Change in GAD7 score
Time frame: From randomization (base line) to endpoint(Week 4)
Change in YMRS score
Time frame: From randomization (base line) to endpoint(Week 4)
Change in CGI-S score
Time frame: From randomization (base line) to endpoint(Week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Results publication: PubMed 17015814Furey ML, Drevets WC. Antidepressant efficacy of the antimuscarinic drug scopolamine: a randomized, placebo-controlled clinical trial. Arch Gen Psychiatry. 2006 Oct;63(10):1121-9. doi: 10.1001/archpsyc.63.10.1121.
- Derived from this study: PubMed 32655854Zhou J, Yang J, Zhu X, Zghoul T, Feng L, Chen R, Wang G. The effects of intramuscular administration of scopolamine augmentation in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled trial. Ther Adv Psychopharmacol. 2020 Jul 1;10:2045125320938556. doi: 10.1177/2045125320938556. eCollection 2020.
- Derived from this study: PubMed 30626409Zhou J, Wang W, Yang J, Zhu X, Feng L, Xiao L, Wang G. Scopolamine augmentation of a newly initiated escitalopram treatment for major depressive disorder: study protocol for a randomized controlled trial. Trials. 2019 Jan 9;20(1):33. doi: 10.1186/s13063-018-3132-3.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Gang Wang, M.D.,Ph.D. principal investigator
Beijing Anding Hospital, Capital Medical 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 Scopolamine, Escitalopram and Saline in people with Major Depressive Disorder, run by Capital Medical University at 1 site in China.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 26 Dec 2018. 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The time of early onset (time frame: From randomization (base line) to endpoint(Week 4)). 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 NCT03131050, which also lists 3 linked publications.
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 26 Dec 2018.