Effectiveness Study of Scopolamine Combined With Escitalopram in Patients With MDD

NCT03131050 | Completed Phase 4 DMC

• 1 other identifier: Scopolamine i.m.
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Scopolamine

Outcome Measures

Primary Outcomes (1)

• The time of early onset

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

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

Secondary Outcomes (8)

• Response rate of patients receiving scopolamine

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

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

  endpoint(Week 4)

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

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

• Change in Montgomery-Asberg Depression Rating Scale(MADRS)

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

• Change in QIDS-SR16 score

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

Other Outcomes (1)

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

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

Study Arms (3)

High-dose scopolamine add-on therapy

EXPERIMENTAL

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

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

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

Drug: Escitalopram; Drug: Saline

Interventions

Scopolamine DRUG

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

High-dose scopolamine add-on therapy; Low-dose scopolamine add-on therapy

Escitalopram DRUG

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

High-dose scopolamine add-on therapy; Low-dose scopolamine add-on therapy; Placebo add-on therapy

Saline DRUG

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

Low-dose scopolamine add-on therapy; Placebo add-on therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Anding Hospital

Beijing, China

Location

Related Publications (3)

• 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.

  PMID: 17015814 RESULT

• 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.

  PMID: 32655854 DERIVED

• 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.

  PMID: 30626409 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Scopolamine; Escitalopram; Sodium Chloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Gang Wang, M.D.,Ph.D.

  Beijing Anding Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Beijing Anding Hospital

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 27, 2017
• Study Start: March 15, 2017
• Primary Completion: February 8, 2018
• Study Completion: March 8, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)