Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT04211961
Eligibility Criteria:
Inclusion Criteria:
To be eligible for inclusion, each participant must meet all of the following inclusion criteria at Screening (Visit 1) and must continue to fulfil these criteria at Visit 2 to take part in the trial:
1. Diagnosis of Bipolar Disorder according to Diagnostic Statistics Manual (DSM)-V criteria
2. Experiencing an episode of depression of at least moderate severity at Visit 1 (Screening) and Visit 2 based on clinical interview by a trained clinician and a Hamilton Depression Rating Scale (HDRS) score ≥ 14.
3. ≥ 18 years old at Visit 2 (male or female)
4. In the opinion of the Principal Investigator or Sub Investigator's, be able and willing to provide written informed consent and to comply with the requirements of this study protocol.
5. Written informed consent prior to participating in the study
6. Urea and Electrolytes (U\&Es), Liver Function Tests (LFTs) and Thyroid Function Tests (TFTs) laboratory tests within acceptable ranges in the previous 4 months of the Screening Visit (Visit 1).
Placebo run-in inclusion criteria at Randomisation visit (Visit 3):
7. In addition to above, participants must be experiencing an episode of depression of at least mild severity (having previously experienced an episode of moderate depression at Visit 2 with HDRS ≥14), based on clinical interview by a trained clinician and a HDRS score of ≥ 8.
Exclusion Criteria:
Participants who meet any one or more of the following exclusion criteria at Screening (Visit 1) or the Visit 2 will not be eligible to take part in the trial:
1. History of other Axis I diagnosis (including Recurrent Depressive Disorder or Psychotic Disorders such as schizo-affective disorder, conditions that can also present with depressive episodes)
2. History in the three months prior to Visit 2 of alcohol dependence syndrome or substance dependence syndrome.
3. Current use of oral steroid at Visit 1
4. A confirmed diagnosis of dementia
5. A diagnosis of intellectual disability (IQ \< 70)
6. Participants with bipolar disorder that are euthymic in the investigators opinion at screening or Visit 2.
7. Participants with bipolar disorder that are hypomanic or manic (Young Mania Rating Scale (YMRS) \> 6) at screening or Visit 2.
8. Presence of an established neurological disorder or other serious demyelinating conditions as determined by the treating physician (e.g. space occupying lesion, multiple sclerosis)
9. Current involuntary detention under the Mental Health Act (MHA) 2001 in an acute psychiatric inpatient unit
10. Severity of Bipolar Disorder is such that participation in a clinical trial is not appropriate because of the risk of imminent self-harm (based on clinical note review and review at screening visit by experienced clinician)
11. A history of an allergic reaction or sensitivity to Scopolamine (Hyoscine Hydrobromide). Participants will be asked at the screening visit about any previous treatment with scopolamine (Hyoscine Hydrobromide) to ascertain any previous allergic reaction or sensitivity to this agent.
12. A clinical diagnosis of narrow angle glaucoma, myasthenia gravis, paralytic ileus,pyloric stenosis, toxic megacolon and acute porphyria.
13. Individuals will be excluded from the study if currently prescribed anticholinergic medications, including Physostigmine, Biperiden and Procyclidine. Individuals will additionally be excluded if currently prescribed Tricyclic Antidepressants which are associated with significant anticholinergic properties (e.g. Amitriptyline and Nortriptyline) that are currently causing the participant to experience anticholinergic side effects (e.g. blurred vision, constipation, urinary retention, cognitive difficulties). No individuals will have anticholinergic medications stopped to allow them enter the trial.
14. Bradycardia \< 50 bpm, tachycardia \> 100bpm or hypotension (systolic BP \<90 and / or diastolic BP \< 60) prior to IV administration of placebo or Scopolamine
15. A recent history in the last 6 months of symptomatic orthostatic hypotension or syncope.
16. Previous participation in this trial. Participation is defined as randomised. Participation in another trial within 3 months prior to Visit 1. Receipt of any investigational medicinal product (IMP) within 3 months prior to Visit 1.
17. Participants concurrently being administered Electroconvulsive Therapy (ECT).
18. Pregnancy, as determined by a positive urine dipstick at Visits 2, 3, 4, 5, positive blood serum result executed at Visit 2 and confirmed prior to infusion at Visit 3 or participants who are actively breastfeeding (female only).
19. Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment. Highly effective contraception methods include:
* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment.
* Male partner sterilization
* Combination of any two of the following:
1. Barrier methods of contraception e.g. Condom
2. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception
3. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
* Women who are considered post-menopausal i.e. amenorrhea at least 12 months or undergone hysterectomy/bilateral oophorectomy
20. Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol
Placebo run-in exclusion criteria at Randomisation visit (Visit 3):
21. In addition to having completed Visit 2, participants must not be experiencing a hypomanic, or manic episode (YMRS \>6).
22. A Serious Adverse Event (SAE) experienced during infusion which required medical intervention and whereby attending physician deemed it inappropriate for the participant to engage in future infusions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04211961
Study Brief:
Protocol Section:
NCT04211961