A randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the efficacy and safety of risperidone long-acting injectable for the prevention of mood episodes in the treatment of subjects with bipolar I disorder

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-001490-15-GR
• Date of registration: 09/10/2006
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V
• Public title: A randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the efficacy and safety of risperidone long-acting injectable for the prevention of mood episodes in the treatment of subjects with bipolar I disorder
• Scientific title: A randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the efficacy and safety of risperidone long-acting injectable for the prevention of mood episodes in the treatment of subjects with bipolar I disorder
• Date of first enrolment: 27/02/2007
• Target sample size: 720
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001490-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Greece

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects may be male or female and must be between the ages of 18 and 65 years, inclusive.
Subjects must have a diagnosis of bipolar I disorder as defined by
DSM-IV-TR criteria. All diagnoses will be confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.). Subjects who present with additional signs or symptoms compatible with Axis I diagnoses of social anxiety disorder or generalized anxiety disorder are acceptable. All other comorbid or active Axis I diagnoses are excluded. Personality disorders as defined by DSM IV TR criteria are acceptable, with the exception of antisocial and borderline personality disorders.
Subjects must be currently experiencing a manic or mixed episode (YMRS >20 and CGI-S ³4 [moderate]) or must be between mood episodes (non-acute; YMRS <12 and CGI-S £3 [mild]).
Subjects must have had at least 2 bipolar mood (manic, mixed manic, or depressed) episodes, exclusive of the current episode (if applicable), during the last year. For non-acute subjects (YMRS <12 and CGI-S £3 [mild]), one manic episode must have occurred within 4 months of enrollment.
Subjects who are non-acute (YMRS <12 and CGI-S £3 [mild]) and are currently receiving an antipsychotic other than risperidone or a mood stabilizer must have received this other medication at the same dosage for a minimum of 4 weeks and must be either experiencing problems of safety or tolerability with the antipsychotic or mood stabilizer or request a change of medication.
Outpatients must not be a danger to themselves or others, and must have sufficient medical monitoring and family support available to be maintained as outpatients. The outpatient status may include partial care or day hospital care, or other forms of outpatient care while the subject resides with his or her family or similar home care providers.
Subjects with a history of ADHD, anxiety disorder, or panic disorder are acceptable if this is not the primary diagnosis.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Having a history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening.
Having received an experimental drug or used an experimental medical device within 30 days prior to screening.
Having a history of ADHD, anxiety disorder, or panic disorder as the primary diagnosis.
Meeting DSM-IV-TR criteria for a hypomanic or depressive episode.
Meeting DSM-IV-TR criteria for any comorbid or active Axis I disorder other than those specifically allowed in the Inclusion Criteria.
Meeting DSM-IV-TR criteria for antisocial or borderline personality disorder.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Subjects with a diagnosos of bipolar I disorder who are currently experiencing a manic or mixed episode (YMRS>20 and CGI-S>/= 4 [moderate]) or who are between mood episodes (non-acute; YMRS<12 and CGI-SMedDRA version: 8.1 Level: LLT Classification code 10004939 Term: Bipolar I disorder

Intervention(s)

Trade Name: Risperdal
Product Name: Risperdal 1 mg
Product Code: F005
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RISPERIDONE
CAS Number: 106266062
Current Sponsor code: R064776
Other descriptive name: risperidone tablet
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 1-6

Trade Name: Risperdal CONSTA
Product Name: Risperdal Consta/25 mg
Product Code: F109
Pharmaceutical Form: Injection*
INN or Proposed INN: RISPERIDONE
CAS Number: 106266062
Current Sponsor code: R064776
Other descriptive name: Risperidone LAI
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intramuscular use

Trade Name: Zyprexa
Product Name: Olanzapine
Product Code: F292
Pharmaceutical Form: Capsule*
INN or Proposed INN: OLANZAPINE
CAS Number: 132539061
Other descriptive name: Zyprexa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Risperdal CONSTA
Product Name: Risperdal Consta/37,5 mg
Product Code: F109
Pharmaceutical Form: Injection*
INN or Proposed INN: RISPERIDONE
CAS Number: 106266062
Current Sponsor code: R064776
Other descriptive name: Risperidone LAI
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 37,5-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intramuscular use

Trade Name: Risperdal CONSTA
Product Name: Risperdal Consta/50 mg
Product Code: F109
Pharmaceutical Form: Injection*
INN or Proposed INN: RISPERIDONE
CAS Number: 106266062
Current Sponsor code: R064776
Other descriptive name: Risperidone LAI
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intramuscular

Primary Outcome(s)

Main Objective: To evaluate the efficacy of risperidone long-acting injectable (LAI) versus placebo in the prevention of a mood episode (recurrence event) in subjects with bipolar I disorder after a 12-week (3-month) stabilazion period on risperidone LAI, as measured by the time to recurrence of any mood episode.

Secondary Objective: To evaluate the prevention of a mood episode with risperidone LAI versus placebo
To evaluate overall duration of treatment of risperidone LAI versus placebo
To evaluate the sustained efficacy of maintenance treatment with risperidone LAI versus placebo.
To perform exploratory comparisons between risperidone LAI and olanzapine as well as between olanzapine and placebo with regard to all items mentioned above
To evaluate the long-term safety of risperidone LAI in subjects with bipolar I disorder

Primary end point(s): A recurrence with a mood episode. The study will end when at least 142 subjects have a recurrence with a mood episode in Period III.

Secondary ID(s)

RIS-BMN-3001