Scopolamine in Bipolar Depression (NCT04211961) | Clinical Trial Compass
CompletedPhase 2
Scopolamine in Bipolar Depression
Ireland55 participantsStarted 2021-03-23
Plain-language summary
This is a single-site, randomised, double-blind, placebo-controlled, parallel, phase IIb clinical trial. The primary objective of the SCOPE-BD study is to investigate the efficacy and safety of IV Scopolamine, compared to placebo, in reducing severity of depression in individuals with bipolar disorder who are experiencing a depressive episode of at least moderate severity
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosis of Bipolar Disorder according to Diagnostic Statistics Manual (DSM)-V criteria
✓. 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.
✓. ≥ 18 years old at Visit 2 (male or female)
✓. 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.
✓. Written informed consent prior to participating in the study
✓. 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).
✓. 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
✕. 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)
✕. History in the three months prior to Visit 2 of alcohol dependence syndrome or substance dependence syndrome.
✕
What they're measuring
1
Hamilton Depression Rating Scale Score After Last Treatment
Timeframe: Approximately 2 weeks after randomisation (Visit 6)
✕. A diagnosis of intellectual disability (IQ \< 70)
✕. Participants with bipolar disorder that are euthymic in the investigators opinion at screening or Visit 2.
✕. Participants with bipolar disorder that are hypomanic or manic (Young Mania Rating Scale (YMRS) \> 6) at screening or Visit 2.
✕. Presence of an established neurological disorder or other serious demyelinating conditions as determined by the treating physician (e.g. space occupying lesion, multiple sclerosis)