Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD): Pilot, Randomized and Controlled Clinical Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

CCAB Centro Clinico Academico Braga Associacao

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

19 Aug 2024 → ongoing

Decision date (initial)

2024-05-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fundação Luso-Americana para o Desenvolvimento (FLAD)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Efficacy

Evaluate the effectiveness of using pramipexole as a strategy for boosting SSRIs, in three different doses, in the treatment of resistant OCD.

Secondary objectives 2

1. Evaluate the safety of using pramipexole in the treatment of resistant OCD.
2. Study the biochemical, neurobiological and psychometric changes in people with resistant OCD.

Conditions and MedDRA coding

Obsessive-compulsive disorder (OCD)

Study design 1 period

Regulatory references

Scientific advice from competent authorities

National Authority Of Medicines And Health Products

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients diagnosed with OCD according to DSM-5 and/or ICD-10 criteria.
2. Age between 18 and 64 years old
3. European Portuguese as mother tongue
4. Score ≥ 16 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
5. Have demonstrated resistance to first-line treatments for OCD, as defined by: Lack of response to pharmacological treatment with at least two selective serotonin reuptake inhibitors (SSRIs) at the maximum tolerated therapeutic dose (Fluoxetine 40-60mg/day; Fluvoxamine 100-300mg/day; Escitalopram 10-30mg/day; Citalopram 20-60 mg/day; Paroxetine 40-60mg/day and Sertraline 100-300mg/day) for at least 12 weeks, i.e., patients who show less than a 25% reduction in Y-BOCS score compared to the score obtained before starting SSRI treatment or patients who maintain a score ≥ 16 on the Y-BOCS after SSRI treatment; and Lack of response to pharmacological treatment with risperidone or aripiprazole as augmentation of SSRIs at the maximum tolerated therapeutic dose (Risperidone 0.5-4 mg/day, Aripiprazole 5-15 mg/day) for at least 6 to 12 weeks, i.e., patients who show less than a 25% reduction in Y-BOCS score compared to the score obtained before starting antipsychotic treatment or patients who maintain a score ≥ 16 on the Y-BOCS after antipsychotic treatment.
6. In the case of participants of childbearing potential, it is necessary for them to consistently and correctly use one of the contraceptive methods presented in section 4.4.1.

Exclusion criteria 19

1. Patients with a current or previous history of psychotic illness (schizophrenia, delusions, among others)
2. Patients undergoing deep brain stimulation
3. Presence of sensory deficits that prevent participation in the clinical study
4. Pregnant or breastfeeding women
5. Patients who are undergoing or have undergone psychotherapy in the last 6 months
6. Patients taking medication or receiving prohibited treatments
7. Allergy to pramipexole and any of its excipients
8. Patients with creatinine clearance ≤ 50 ml/min (calculated using the Cockcroft-Gault formula)
9. Patients with NYHA III or IV heart failure or any other severe cardiovascular disease
10. Hypotension (<90/60 mmHg) in the sitting position and orthostatic hypotension (drop in systolic BP ≥20 mmHg or diastolic BP ≥10 mmHg after 2-3 minutes in standing position) at the screening appointment;
11. Patients with bipolar disorder
12. Patients with tic disorders
13. Patients with borderline personality disorder
14. Patients with social anxiety disorder
15. Patients with a current or previous history of eating disorder in the last 6 months
16. Patients with a history of neurological disease or traumatic brain injury
17. Patients with a history of alcohol or illicit substance abuse in the last 6 months
18. Patients who are experiencing or have experienced a major depressive episode in the last 6 months
19. Patients with contraindications to undergo MRI cannot participate in the assessment of the exploratory endpoint

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Difference in the total score of the Y-BOCS scale between baseline (V1; before intervention with the investigational drug) and week 16 (V9; after intervention with the investigational drug), between the different groups treated with different doses of pramipexole.

Secondary endpoints 1

1. Number of adverse events observed (nonserious, serious not related to the investigational medicinal product, and serious related to the investigational medicinal product) from day 2 (V1; after the first dose of the investigational medicinal product) to the week 24 (V11; end of study) in the different pramipexole treatment groups.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CCAB Centro Clinico Academico Braga Associacao

Sponsor organisation

CCAB Centro Clinico Academico Braga Associacao

Address

Lugar De Sete Fontes S Victor

City

Braga

Postcode

4710-243

Country

Portugal

Scientific contact point

Organisation

CCAB Centro Clinico Academico Braga Associacao

Contact name

Clinical Project Manager

Public contact point

Organisation

CCAB Centro Clinico Academico Braga Associacao

Contact name

Executive director

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications