E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066364 |
E.1.2 | Term | Hypersexuality |
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 |
The aim of this pilot study is to assess feasibility, efficacy and tolerability of Naltrexone treatment in patients with hypersexual disorder. The following research questions will be asked: 1. Is treatment with Naltrexone feasible for patients with Hypersexual disorder treated at a sub specialized unit? 2. Does Naltrexone reduce symptoms in patients with Hypersexual disorder? And if so, what clinical characteristics predict response? 3. What is the tolerability of Naltrexone in patients with Hypersexual disorder? |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• A diagnosis of hypersexual disorder (as described in the protocol). • 18- 65 years old • Signed informed consent • Able to understand the Swedish language orally and in written, write in Swedish and able to use the internet including having succeeded in filling out online questionnaires. • Willing to participate to all study visits including giving blood and urine samples.
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E.4 | Principal exclusion criteria |
• Elevated liver enzymes (greater than three times the upper limit of normal for ALAT and/or ASAT). • Ongoing opioid or benzodiazepine medication. • Illicit self-reported use of drugs in the past month or positive drug verification analysis. • Risk consumption of alcohol in the past month or alcohol dependence (14 units of alcohol per week for men and 9 units per week for women will be considered risk consumption). • Severe psychiatric disorder such as current psychotic illness or severe depression requiring immediate treatment. • History of liver or kidney failure. • Serious physical illness. • Change of medication or dosage in the last 3 months regarding antidepressants, ADHD-medication, mood stabilizers, anti-psychotics, cortisone, testosterone or precursor of Dopamine such as L-Dopa. • Pregnancy and/or breast-feeding. • Ongoing psycho-therapeutic treatment. • History of allergic reaction to Naltrexone or its metabolites. • Other factors that are clinical significant and could jeopardize study results or its intention, as judged by study psychiatrist or psychologist.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Feasibility: Assessed continually as the research group evaluate the procedures and receive input from patients. 2. Effect: self- assessment HD: CAS 3. Tolerability: - Treatment drop out - Self-reported adherence to treatment - Discontinuation/ exclusion from study due to serious adverse effects or elevated liver tests - Reported adverse effects. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Endpoint 1: continuously throughout the study Endpoint 2: week 8 (End of Study) Endpoint 3: week 8 (End of Study) |
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E.5.2 | Secondary end point(s) |
1. Feasibility: None 2. Effect: - HBI assessment - Compare outcome in patients with different clinical characteristics; captured in internet-based questionnaires and at the clinical evaluation 3. Tolerability: None |
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E.5.2.1 | 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 | Yes |
E.6.4 | Safety | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
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.8.5 | 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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
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 | 1 |
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 |