To compare Scopolamine versus Ketamine in Treatment Resistant Depressio

Phase 4

• Registration Number: CTRI/2021/09/036952
• Lead Sponsor: GMC Patiala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Primary diagnosis of MDD without psychotic features based on DSM-5.

Fulfilling TRD (Thase and Rush) criteria, stage II: Failure of at least 2 adequate trials of at least 2 distinctly different classes of anti-depressants.

Ability to remain on adequate stable antidepressant regimen (on & off label treatment) for >4 weeks.

Medically stable for study participation.

Subject will be off the drugs that are likely to interact with glutamate for at least 14 days before the start of study.

Participants who will give voluntary informed consent.

Exclusion Criteria

�History of chronic psychosis or drug induced psychosis of any kind.

�Currently, DSM-5 diagnosis of drug abuse/dependence in the last six months and has a negative drug screen at baseline.

�Women will be excluded if they are pregnant, lactating or neither surgically-sterile nor using appropriate methods of birth control. Women must agree to continue using applicable birth control throughout the trial. All women of child-bearing potential must have a negative urine pregnancy test.

�History of seizures, renal insufficiency or congestive heart failure.

�History of clinically significant violence.

�History of ketamine abuse/dependence or prior clinically significant adverse reaction to ketamine.

�Current alcohol abuse or dependence.

�Untreated hypertension (Systolic B.P >130mmHg and/or Diastolic B.P >80mmHg).

�Clinically, abnormal liver function tests (LFTs), thyroid, renal function or anemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified