Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia

Sponsor
Takeda
Study ID
NCT02079844
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Roflumilast tablets
  • Placebo — DRUG
    Roflumilast placebo-matching tablets
  • Second generation antipsychotic — DRUG
    Second Generation Antipsychotic (SGA) medication for standard of care therapy will be sourced and managed locally by the site.

Study Details

The purpose of this study is to determine whether cognitive impairment associated with schizophrenia is attenuated by add-on roflumilast administration to second generation antipsychotics (SGA) in participants with stable schizophrenia.

Key Dates

Start date
Mar 31, 2014
Status verified
Aug 2016
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo + Roflumilast 100 μg + Roflumilast 250 μg
    Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
  • Experimental: Roflumilast 100 μg + Roflumilast 250 μg + Placebo
    Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
  • Experimental: Roflumilast 250 μg + Placebo + Roflumilast 100 μg
    Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.

Primary Outcome Measure

Change From Baseline in Spatial Span Test Score [ Time Frame: Baseline and Day 8 of Treatment Periods 1, 2 and 3 ]

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