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Effectiveness Study of Scopolamine Combined With Escitalopram in Patients With MDD (SCE)

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Scopolamine

Escitalopram

Saline

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Scopolamine

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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

Sites / Locations

Beijing Anding Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

High-dose scopolamine add-on therapy

Low-dose scopolamine add-on therapy

Placebo add-on therapy

Arm Description

Scopolamine (0.3 mg/1 ml, i.m.) Bid; escitalopram （10 mg/d p.o.）QD

Scopolamine (0.3 mg/1 ml, i.m.) QD; placebo (1 ml saline, i.m.) QD; escitalopram （10 mg/d p.o.）QD

Placebo (1 ml saline, i.m.) Bid; escitalopram （10 mg/d p.o.）QD

Outcomes

Primary Outcome Measures

The time of early onset

The time from randomization (baseline) to early improvement (at least 20% reduction in HAMD-17 score )

Secondary Outcome Measures

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.

The proportion of subjects at endpoint with HAMD-17≤7

Remission was defined as the HAMD total score ≤7

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.

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.

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.

Change in GAD7 score

Change in GAD7 score measured by the difference between baseline GAD7 score and GAD7 score at endpoint.

Change in YMRS score

Change in YMRS score measured by the difference between baseline YMRS score and YMRS score at endpoint.

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.

Full Information

NCT ID

NCT03131050

First Posted

April 18, 2017

Last Updated

December 24, 2018

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03131050

Brief Title

Effectiveness Study of Scopolamine Combined With Escitalopram in Patients With MDD

Acronym

SCE

Official Title

A Double-blind, Controlled, Randomized Study Comparing Escitalopram Combined With Scopolamine or Escitalopram in Patients With Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

March 15, 2017 (Actual)

Primary Completion Date

February 8, 2018 (Actual)

Study Completion Date

March 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Scopolamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-dose scopolamine add-on therapy

Arm Type

Experimental

Arm Description

Scopolamine (0.3 mg/1 ml, i.m.) Bid; escitalopram （10 mg/d p.o.）QD

Arm Title

Low-dose scopolamine add-on therapy

Arm Type

Experimental

Arm Description

Scopolamine (0.3 mg/1 ml, i.m.) QD; placebo (1 ml saline, i.m.) QD; escitalopram （10 mg/d p.o.）QD

Arm Title

Placebo add-on therapy

Arm Type

Placebo Comparator

Arm Description

Placebo (1 ml saline, i.m.) Bid; escitalopram （10 mg/d p.o.）QD

Intervention Type

Drug

Intervention Name(s)

Scopolamine

Intervention Description

Intramuscular injection with scopolamine (0.3 mg/1ml,QD or Bid) during the first three days;

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Intervention Description

Oral escitalopram 10 mg/d throughout the total of 4 weeks treatment

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

Intramuscular injection with saline (1ml, QD or Bid) during the first three days;

Primary Outcome Measure Information:

Title

The time of early onset

Description

The time from randomization (baseline) to early improvement (at least 20% reduction in HAMD-17 score )

Time Frame

From randomization (base line) to endpoint(Week 4)

Secondary Outcome Measure Information:

Title

Response rate of patients receiving scopolamine

Description

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.

Time Frame

From randomization (base line) to endpoint(Week 4)

Title

The proportion of subjects at endpoint with HAMD-17≤7

Description

Remission was defined as the HAMD total score ≤7

Time Frame

endpoint(Week 4)

Title

Change in 17-item Hamilton Depression Scale (HAMD-17) scores

Description

Change in HAMD-17 scores measured by the difference between baseline HAMD-17 score and HAMD-17 score at endpoint.

Time Frame

From randomization (base line) to endpoint(Week 4)

Title

Change in Montgomery-Asberg Depression Rating Scale(MADRS)

Description

Change in MADRS scores measured by the difference between baseline MADRS score and MADRS score at endpoint.

Time Frame

From randomization (base line) to endpoint(Week 4)

Title

Change in QIDS-SR16 score

Description

Change in QIDS-SR16 score measured by the difference between baseline QIDS-SR16 score and QIDS-SR16 score at endpoint.

Time Frame

From randomization (base line) to endpoint(Week 4)

Title

Change in GAD7 score

Description

Change in GAD7 score measured by the difference between baseline GAD7 score and GAD7 score at endpoint.

Time Frame

From randomization (base line) to endpoint(Week 4)

Title

Change in YMRS score

Description

Change in YMRS score measured by the difference between baseline YMRS score and YMRS score at endpoint.

Time Frame

From randomization (base line) to endpoint(Week 4)

Title

Change in CGI-S score

Description

Change in CGI-S score measured by the difference between baseline CGI-S score and CGI-S score at endpoint.

Time Frame

From randomization (base line) to endpoint(Week 4)

Other Pre-specified Outcome Measures:

Title

Incidence of treatment-emergent adverse events (safety and tolerability)

Description

The incidence and nature of overall adverse events; the incidence and nature of drug-related adverse events; assessment of cognitive function change by PDQ-D5

Time Frame

From randomization (base line) to endpoint(Week 4)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gang Wang, M.D.,Ph.D.

Organizational Affiliation

Beijing Anding Hospital, Capital Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Anding Hospital

City

Beijing

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17015814

Citation

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.

Results Reference

result

PubMed Identifier

32655854

Citation

Zhou 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.

Results Reference

derived

PubMed Identifier

30626409

Citation

Zhou 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.

Results Reference

derived

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/17015814

Description

Related Info

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Effectiveness Study of Scopolamine Combined With Escitalopram in Patients With MDD

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