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Study · Randomized controlled trial · n = 63 · 2012

9 results

Effect of the neuroprotective peptide davunetide (AL-108) on cognition and functional capacity in schizophrenia.

Javitt DC, Buchanan RW, Keefe RS, Kern R, McMahon RP, Green MF, Lieberman J, Goff DC, Csernansky JG, McEvoy JP, Jarskog F, Seidman LJ and 7 more

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Gold JM, Kimhy D, Nolan KS, Barch DS, Ball MP, Robinson J, Marder SR

Schizophrenia research12 Dec 2011Cited by 100 (Europe PMC)

PMID22169248 (opens in a new tab)DOI10.1016/j.schres.2011.11.001 (opens in a new tab)PepBankPUB-22169248
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In schizophrenia, MCCB change did not significantly differ between davunetide and placebo across three arms (p=.45).

    In plain wordsIn people with schizophrenia, davunetide did not significantly change cognition scores compared with placebo.

    Peptide
    Davunetide
    Outcome
    No significant changeMCCB change across arms
    Study

    n = 63

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    5 mg or 30 mg · intranasal · 12 weeksAs given in this study (human).

    Measurements

    P value
    0.45 NA
    MCCB change across three arms

    Source sentences

    Summary
    There were no significant differences in MCCB change between davunetide and placebo over the three treatment arms (p=.45).
    2 context sentences
    Summary · context
    Sixty-three subjects with schizophrenia received davunetide at one of two different doses (5, 30 mg) or placebo for 12 weeks in a multicenter, double-blind, parallel-group randomized clinical trial.
    Summary · context
    Subjects continued their current antipsychotic treatment during the trial.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In schizophrenia, UPSA showed a significant main treatment effect across davunetide and placebo arms (p=.048).

    In plain wordsIn people with schizophrenia, functional skills scores showed a significant treatment effect across davunetide and placebo groups.

    Peptide
    Davunetide
    Outcome
    IncreaseUPSA treatment effect
    Study

    n = 63

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    5 mg or 30 mg · intranasal · 12 weeksAs given in this study (human).

    Measurements

    P value
    0.048 NA
    UPSA main effect of treatment across arms

    Source sentences

    Summary
    For UPSA, there was a significant main effect of treatment across study arms (p=.048).
    3 context sentences
    Summary · context
    In contrast, a significant beneficial effect was detected for the UPSA.
    Summary · context
    Sixty-three subjects with schizophrenia received davunetide at one of two different doses (5, 30 mg) or placebo for 12 weeks in a multicenter, double-blind, parallel-group randomized clinical trial.
    Summary · context
    Subjects continued their current antipsychotic treatment during the trial.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In schizophrenia, davunetide showed no significant effect on SCoRS compared with placebo.

    In plain wordsIn people with schizophrenia, davunetide did not significantly change SCoRS scores compared with placebo.

    Peptide
    Davunetide
    Outcome
    No significant changeSCoRS
    Study

    n = 63

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    Dose not stated · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant effects were observed on the SCoRS or on symptom ratings.
    2 context sentences
    Summary · context
    Sixty-three subjects with schizophrenia received davunetide at one of two different doses (5, 30 mg) or placebo for 12 weeks in a multicenter, double-blind, parallel-group randomized clinical trial.
    Summary · context
    Subjects continued their current antipsychotic treatment during the trial.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In schizophrenia, davunetide showed no significant effect on symptom ratings compared with placebo.

    In plain wordsIn people with schizophrenia, davunetide did not significantly change symptom ratings compared with placebo.

    Peptide
    Davunetide
    Outcome
    No significant changeSymptom ratings
    Study

    n = 63

    Comparator
    Placebo
    Outcome group
    Psychiatric symptoms · Mental health and mood
    Studied dose
    Dose not stated · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant effects were observed on the SCoRS or on symptom ratings.
    2 context sentences
    Summary · context
    Sixty-three subjects with schizophrenia received davunetide at one of two different doses (5, 30 mg) or placebo for 12 weeks in a multicenter, double-blind, parallel-group randomized clinical trial.
    Summary · context
    Subjects continued their current antipsychotic treatment during the trial.
  5. 05HumanRandomized controlled trialSafety outcome

    In schizophrenia, the davunetide trial reported no significant side effects or adverse events.

    In plain wordsIn people with schizophrenia, the davunetide trial reported no significant side effects or adverse events.

    Peptide
    Davunetide
    Outcome
    Direction not reportedSide effects and adverse events
    Study

    n = 63

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant side effects or adverse events were observed.
    2 context sentences
    Summary · context
    Sixty-three subjects with schizophrenia received davunetide at one of two different doses (5, 30 mg) or placebo for 12 weeks in a multicenter, double-blind, parallel-group randomized clinical trial.
    Summary · context
    Subjects continued their current antipsychotic treatment during the trial.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In schizophrenia, the MCCB effect size favored davunetide 5 mg versus placebo (d=.34), without a significant overall treatment difference.

    In plain wordsIn people with schizophrenia, the cognition effect size favored low-dose davunetide over placebo, but the overall difference was not significant.

    Peptide
    Davunetide
    Outcome
    No significant changeMCCB effect size, low dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    5 mg · intranasal · 12 weeksAs given in this study (human).

    Measurements

    Effect size
    0.34 d
    5 mg versus placebo

    Source sentences

    Summary
    Estimated effect-size (d) values were .34 and .21 favoring the 5 and 30 mg doses vs. placebo, respectively.
    3 context sentences
    Summary · context
    There were no significant differences in MCCB change between davunetide and placebo over the three treatment arms (p=.45).
    Summary · context
    Sixty-three subjects with schizophrenia received davunetide at one of two different doses (5, 30 mg) or placebo for 12 weeks in a multicenter, double-blind, parallel-group randomized clinical trial.
    Summary · context
    Subjects continued their current antipsychotic treatment during the trial.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In schizophrenia, the MCCB effect size favored davunetide 30 mg versus placebo (d=.21), without a significant overall treatment difference.

    In plain wordsIn people with schizophrenia, the cognition effect size favored high-dose davunetide over placebo, but the overall difference was not significant.

    Peptide
    Davunetide
    Outcome
    No significant changeMCCB effect size, high dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    30 mg · intranasal · 12 weeksAs given in this study (human).

    Measurements

    Effect size
    0.21 d
    30 mg versus placebo

    Source sentences

    Summary
    Estimated effect-size (d) values were .34 and .21 favoring the 5 and 30 mg doses vs. placebo, respectively.
    3 context sentences
    Summary · context
    There were no significant differences in MCCB change between davunetide and placebo over the three treatment arms (p=.45).
    Summary · context
    Sixty-three subjects with schizophrenia received davunetide at one of two different doses (5, 30 mg) or placebo for 12 weeks in a multicenter, double-blind, parallel-group randomized clinical trial.
    Summary · context
    Subjects continued their current antipsychotic treatment during the trial.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In schizophrenia, the UPSA between-group effect size favored davunetide 5 mg over placebo (d=.74).

    In plain wordsIn people with schizophrenia, the functional skills effect size favored low-dose davunetide over placebo.

    Peptide
    Davunetide
    Outcome
    IncreaseUPSA effect size, low dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    5 mg · intranasal · 12 weeksAs given in this study (human).

    Measurements

    Effect size
    0.74 d
    5 mg versus placebo

    Source sentences

    Summary
    Between-group effect size (d) values were.74 and .48, favoring the 5 and 30 mg doses, respectively.
    3 context sentences
    Summary · context
    For UPSA, there was a significant main effect of treatment across study arms (p=.048).
    Summary · context
    Sixty-three subjects with schizophrenia received davunetide at one of two different doses (5, 30 mg) or placebo for 12 weeks in a multicenter, double-blind, parallel-group randomized clinical trial.
    Summary · context
    Subjects continued their current antipsychotic treatment during the trial.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In schizophrenia, the UPSA between-group effect size favored davunetide 30 mg over placebo (d=.48).

    In plain wordsIn people with schizophrenia, the functional skills effect size favored high-dose davunetide over placebo.

    Peptide
    Davunetide
    Outcome
    IncreaseUPSA effect size, high dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    30 mg · intranasal · 12 weeksAs given in this study (human).

    Measurements

    Effect size
    0.48 d
    30 mg versus placebo

    Source sentences

    Summary
    Between-group effect size (d) values were.74 and .48, favoring the 5 and 30 mg doses, respectively.
    3 context sentences
    Summary · context
    For UPSA, there was a significant main effect of treatment across study arms (p=.048).
    Summary · context
    Sixty-three subjects with schizophrenia received davunetide at one of two different doses (5, 30 mg) or placebo for 12 weeks in a multicenter, double-blind, parallel-group randomized clinical trial.
    Summary · context
    Subjects continued their current antipsychotic treatment during the trial.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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