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Scopolamine in Bipolar Depression
Phase 2 trial testing Placebo / Saline in Bipolar Disorder Depression in 55 participants. Completed in 22 February 2024.
| Lead sponsor | Dr. Brian Hallahan |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 23 March 2021 |
| Primary completion | 22 February 2024 |
| Estimated completion | 22 February 2024 |
| Sites | 1 location across Ireland |
Dr. Brian Hallahan
18 and older, any sex, with Bipolar Disorder Depression. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Severity of objective depressive symptoms after the final scheduled treatment (Visit 6) as measured by the Hamilton Depression Rating Scale score. Possible scale range is 0-54, with higher values indicating greater severity of Depression.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 12.0 | 7.0 – 15.5 |
| Scopolamine | 13.0 | 10.8 – 17.0 |
Remission of depressive episode after the last IV treatment (measured objectively at Visit 6), defined as occurring when an individual has a Hamilton Depression Rating Scale score \<= 7 and a Montgomery and Asberg Depression Scale (MADRS) score \<6. The Hamilton Depression Rating Scale possible scale range is 0-54, with higher values indicating greater severity of Depression. The Montgomery-Åsberg Depression Rating Scale Score possible range is 0-60 with higher scores indicating greater severity of Depression.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 2 | |
| Scopolamine | 2 |
Remission of depressive episode at followup (measured objectively at Visit 7), defined as occurring when an individual has a Hamilton Depression Rating Scale score \<= 7 and a Montgomery and Asberg Depression Scale (MADRS) score \<6. he Hamilton Depression Rating Scale possible scale range is 0-54, with higher values indicating greater severity of Depression. The Montgomery-Åsberg Depression Rating Scale Score possible range is 0-60 with higher scores indicating greater severity of Depression.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 4 | |
| Scopolamine | 1 |
Response to a depressive episode after the last IV treatment (measured at Visit 6) defined as a 50% reduction in Montgomery-Åsberg Depression Rating Scale score at Visit 6 compared to Visit 3. The Montgomery-Åsberg Depression Rating Scale Score possible range is 0-60 with higher scores indicating greater severity of Depression.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 9 | |
| Scopolamine | 7 |
Response at Visit 7, defined as a 50% reduction in Montgomery-Åsberg Depression Rating Scale score at Visit 7 compared to Visit 3.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 7 | |
| Scopolamine | 6 |
Montgomery-Åsberg Depression Rating Scale Score After Last Treatment (Visit 6). The The Montgomery-Åsberg Depression Rating Scale Score possible range is 0-60 with higher scores indicating greater severity of Depression.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 14 | 9 – 20 |
| Scopolamine | 16 | 10 – 27 |
POMS profile of mood scale is a questionnaire containing 65 words/statements that describe feelings people have. Total Score has range from 0-200 with higher scores indicating greater mood disturbance.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 27 | 9 – 51 |
| Scopolamine | 41 | 16 – 93 |
Severity of objective depressive symptoms at followup (Visit 7) as measured by the Hamilton Depression Rating Scale score. Possible scale range is 0-54, with higher values indicating greater severity of Depression.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 9 | 5 – 14 |
| Scopolamine | 12 | 10 – 15 |
Montgomery-Åsberg Depression Rating Scale Score at followup (Visit 7). The Montgomery-Åsberg Depression Rating Scale Score possible range is 0-60 with higher scores indicating greater severity of Depression.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 14 | 9 – 20 |
| Scopolamine | 16 | 10 – 27 |
POMS profile of mood scale is a questionnaire containing 65 words/statements that describe feelings people have. Total Score has range from 0-200 with higher scores indicating greater mood disturbance.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 19 | 2 – 65 |
| Scopolamine | 61 | 30 – 84 |
Antidepressants medication initiation by a participant due to depressive episodes over the duration of the study (Visit 2 to Visit 7): (i) Introduction of a new antidepressant (yes / no)
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 2 | |
| Scopolamine | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 4 | |
| Scopolamine | 4 |
Time frame: From randomisation through to study completion, an average of about 4 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Scopolamine |
|---|---|---|---|
| Depressed mood | Psychiatric disorders | — | — |
| Emotional distress | Psychiatric disorders | — | — |
| Suspected suicide | Psychiatric disorders | — | — |
| Reaction | System | Placebo | Scopolamine |
|---|---|---|---|
| Dizziness | Nervous system disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Somnolence | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Thirst | General disorders | — | — |
| Vision blurred | Eye disorders | — | — |
| Endometriosis | Reproductive system and breast disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Tension headache | Nervous system disorders | — | — |
| Tremor | Nervous system disorders | — | — |
| Abdominal hernia | Gastrointestinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Acne | Skin and subcutaneous tissue disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Aphthous ulcer | Gastrointestinal disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Blood glucose increased | Investigations | — | — |
| Chills | General disorders | — | — |
| Colonoscopy | Investigations | — | — |
| Confusional state | Psychiatric disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Dizziness postural | Nervous system disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Dry throat | Respiratory, thoracic and mediastinal disorders | — | — |
| Eye pain | Eye disorders | — | — |
| Feeling abnormal | General disorders | — | — |
| Flushing | Vascular disorders | — | — |
| Gingival abscess | Infections and infestations | — | — |
| Helminthic infection | Infections and infestations | — | — |
| Hot flush | Vascular disorders | — | — |
| Joint swelling | Musculoskeletal and connective tissue disorders | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — |
| Malaise | General disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — |
| Panic reaction | Psychiatric disorders | — | — |
| Paraesthesia | Nervous system disorders | — | — |
Most-reported serious reactions: Depressed mood, Emotional distress, Suspected suicide.
Data from ClinicalTrials.gov NCT04211961 adverse events section.
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
5 peer-reviewed publications reference this trial (live from Europe PMC):
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