Health Condition 1: F341- Dysthymic disorder Health Condition 2: F332- Major depressive disorder, recurrent severe without psychotic features Health Condition 3: F330- Major depressive disorder, recurrent, mild Health Condition 4: F331- Major depressive disorder, recurrent, moderate Health Condition 5: F320- Major depressive disorder, singleepisode, mild Health Condition 6: F321- Major depressive disorder, singleepisode, moderate Health Condition 7: F322- Major depressive disorder, singlee
Conditions
Interventions
Intervention1: scopolamine: scopolamine 4ug/kg will be given i.v. over 15 minutes, two infusions per week as augmentation to the ongoing antidepressant regimen for 2 weeks
Control Intervention1: ketam
Sponsors
GMC Patiala
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures will be early response to treatment by improvement in severity of depression on HAM-D and CGI (Clinical Global Impression) scale. Response will be a more than 50% improvement on HAM-D, remission score HDRS 7 and CGI-S, CGI-I scales.Timepoint: . The observations will be done at baseline, post-infusion 4 hrs, 24 hrs, 48 hrs twice weekly for two weeks. Thereafter, subjects will be followed up every week for one month till the therapeutic effects is lost or patient relapsed. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures will be adverse effects on CADSS, ADR and quality of life on SF-36 scalesTimepoint: The observations will be done at baseline, post-infusion 4 hrs, 24 hrs, 48 hrs twice weekly for two weeks. Thereafter, subjects will be followed up every week for one month till the therapeutic effects is lost or patient relapsed. | — |
Countries
India
Contacts
Public ContactDr Rajnish Raj
GMC Patiala
Outcome results
None listed