E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Late-life (aged 50 or over) unremitted vascular depression. |
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E.1.1.1 | Medical condition in easily understood language |
Late-life (aged 50 or over) vascular depression that is not responding to therapy. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012378 |
E.1.2 | Term | Depression |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To provide estimates of the effectiveness of the study medication, amlodipine, to inform a calculation for a larger more definitive study. We hypothesise that the amlodipine addition (augmentation) to a patients routine treatment will lead to significantly more people achieving remission (a lessening of their symptoms) at 16 weeks when compared with those patients who have the placebo augmentation. This is however a pilot study and as such is not expected to have sufficient numbers of participants to provide definitive proof of this. |
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E.2.2 | Secondary objectives of the trial |
To demonstrate we can identify and recruit sufficient numbers of older people with depression from primary care. To use a qualitative sub-study to assess the validity and relevance to patients of the outcome measures used. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 50 years or older Clinically significant (unremitted) vascular depression, as defined above. MMSE >23 Medically stable BP < 150/90 (Quality and Outcomes Framework Audit standard) Patient has provided written informed consent for participation in the study prior to any study specific procedures |
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E.4 | Principal exclusion criteria |
On calcium channel blocker Clinical evidence of dementia History or evidence of stroke History of bipolar or psychotic disorder Significant suicide risk Known hypersensitivity to amlodipine Severe renal or hepatic impairment Pregnancy, or women planning to become pregnant within next 12 months, or women who are breast feeding. Use of other investigational study drugs within 30 days prior to study entry (defined as date of randomisation into study) Previous participation in this study OPTIONAL MRI Sub Study only - Contraindications for MRI scanning (eg pacemaker in situ, metal fragments in eyes, or unwillingness to undergo MRI scanning) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is presence of remission (HAM-D<10 for 2 consecutive weeks) by 16 weeks of augmentation. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Determine power calculation for definitive study & to determine acceptability & tolerability. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study will be the last participant’s final study assessment, at 20 weeks follow up. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |